tag:blogger.com,1999:blog-75388916408477163242024-03-17T12:22:46.271+05:30Regulatory OneRegulatory One
Regulatory Affairs Simplified!Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.comBlogger29125tag:blogger.com,1999:blog-7538891640847716324.post-53921934751579602462016-01-20T07:19:00.000+05:302016-01-21T21:28:33.133+05:30eCTD Issues for ANDA Submissions<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;">Post the implementation of GDUFA, in the current <span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial; background-position: initial; background-repeat: initial; background-size: initial;">year 4 cohort of FY 2016, there has been a very
significant positive change with respect to ANDA review timelines. The initial
screening deficiencies/ information requests or acceptance letters are generally
being issued within 1 month of filing ANDAs. The most important screening
deficiency/information request issued by USFDA is related to eCTD aspects,
which in general is given least importance. RA professionals generally ensure
to meet the requirements of ANDA Filing Checklist, which doesn’t summarize the
eCTD requirements in detail, but gives a link to USFDA website where we get all
the guidelines and eCTD requirements details.<o:p></o:p></span></span></span></div>
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<span style="background: white; line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;">In this post, the below listed eCTD
aspects will be discussed in detail, as they are important for avoiding eCTD
related deficiencies.</span></span></div>
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<ul>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">PDF Document Properties</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">Fonts and Font Sizes</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">Embedding of Non –Standard Fonts</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">Bookmarks and Hyper Linking</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">Requirements of Scanned Documents</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">Leaf Title Naming (for eCTD XML)</span></li>
</ul>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;">PDF
Document Properties</span></span></b></div>
<ul style="text-align: left;">
<li><span style="line-height: 150%; text-indent: -18pt;"><span style="font-family: "arial" , "helvetica" , sans-serif;">The file name is to be given in
abbreviated form with the use of small letters.”Hyphens (-)” should be used in
place of spaces.”Full Stops (.)”, should not be used.</span></span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="line-height: 150%; text-indent: -18pt;">The
title is generally not given under document properties.</span></span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="line-height: 150%; text-indent: -18pt;">T</span><span style="line-height: 150%; text-align: justify; text-indent: -18pt;">he acceptable PDF Versions are 1.4 to
1.7. Irrespective of the version of Adobe Acrobat, PDF Version should be
anything from 1.4 to 1.7 only.</span></span></li>
<li><span style="line-height: 150%; text-align: justify; text-indent: -18pt;"><span style="font-family: "arial" , "helvetica" , sans-serif;">There should not be any security
passwords for opening the document</span></span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="line-height: 150%; text-align: justify; text-indent: -18pt;">“Fast Web View”, should be yes. If “Fast
Web View” option is being displayed as “no” it has to be changed to “Yes” as
per following procedure - go to “File” option in the menu bar of PDF File, go
to “Save As Other”, then “Reduced Size PDF”. Under “Make Compatible with”
option “Acrobat 5.0 and later” or “Acrobat 6.0 and later” should ideally be
selected. Next “Ok” should be selected. Finally, the file in which this
correction is being done, should be replaced (We get a message – “The file
already exists. Replace existing file”. We should select “Yes” option). After
this procedure, we should ensure PDF version is anything from 1.4 to 1.7 only.</span></span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="line-height: 150%; text-align: justify; text-indent: -18pt;">For Submissions to USFDA, Pages size
should be 8.50 x 11.00 in.</span></span></li>
<li><span style="line-height: 150%; text-align: justify; text-indent: -18pt;"><span style="font-family: "arial" , "helvetica" , sans-serif;">Under Initial View tab - Navigation tab
should be set to “page only”, if the numbers of pages are less than 5 and there
are no bookmarks. Any PDF file with more than 5 pages should be bookmarked in
which case; navigation tab should be set to “Bookmarks Panel and Page”. Page
Layout and Magnification should be set to “Default”.</span></span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="line-height: 150%; text-align: justify; text-indent: -18pt;"><span style="font-stretch: normal; line-height: normal;"> </span></span><span style="line-height: 150%; text-align: justify; text-indent: -18pt;">The maximum length of the filename
should be 64 characters.</span></span></li>
<li><span style="line-height: 150%; text-align: justify; text-indent: -18pt;"><span style="font-family: "arial" , "helvetica" , sans-serif;">The leaf element path length should not
exceed 230 characters.</span></span></li>
</ul>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;"><br /></span></span></b></div>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;">Fonts
and Font Sizes <o:p></o:p></span></span></b></div>
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<ul>
<li><span style="line-height: 150%; text-indent: -18pt;"><span style="font-family: "arial" , "helvetica" , sans-serif;">Times New Roman 12-point font, is
recommended and should be preferred for narrative text.</span></span></li>
<li><span style="line-height: 150%; text-indent: -18pt;"><span style="font-family: "arial" , "helvetica" , sans-serif;">Point sizes 9-10 are recommended for
tables; smaller point sizes should be avoided.</span></span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="line-height: 150%; text-align: justify; text-indent: -18pt;"><span style="font-stretch: normal; line-height: normal;"> </span></span><span style="line-height: 150%; text-align: justify; text-indent: -18pt;">Point Size 10 is recommended for
footnotes.</span></span></li>
</ul>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;"><br /></span></span></b></div>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;">Embedding
of Non –Standard Fonts</span></span></b></div>
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<ul>
<li><span style="line-height: 150%; text-indent: -18pt;"><span style="font-family: "arial" , "helvetica" , sans-serif;">All the non – standard fonts should be embedded.
PDF viewing software, substitutes non-standard fonts if the font used to create
the text is unavailable on the reviewer’s computer.</span></span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-align: justify; text-indent: -18pt;">In some cases, substitution of standard
fonts like Helvetica or Times is done by PDF viewing software.</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-align: justify; text-indent: -18pt;">Font substitution can affect a
document’s appearance and structure, and in some cases it can affect the
information conveyed by a document. Hence, embedding of fonts should be
ensured.</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-align: justify; text-indent: -18pt;">However, embedding of font should be
avoided for labels and electronically signed documents.</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-align: justify; text-indent: -18pt;">The table with list of standard fonts
are provided below.</span></li>
</ul>
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</v:imagedata></v:shape></span><b><span style="line-height: 150%;"> Image Courtesy: Portable document format
specifications guidance of USFDA</span></b></span></div>
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<b style="line-height: 150%;"><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;"></span></span></b></div>
<span style="font-family: "arial" , "helvetica" , sans-serif;"><span style="line-height: 24px;"><b>Note: </b>There are multiple procedures for “embedding font”. You could Google it and follow. If you are facing any difficulty, I’ll be happy to help out.</span></span><br />
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<b style="line-height: 150%;"><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;">Bookmarks
and Hyper Linking</span></span></b></div>
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</div>
<ul>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">There should be appropriate number of bookmarks
in the document. The number of bookmarks should be neither less nor more.</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">The number of sub heading trees within
book marks should be limited to 3 or 4.</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">If there is table of contents in the
document, the bookmarks should exactly match with the table of contents (naming
and number of bookmarks).</span></li>
<li><b style="font-family: Arial, Helvetica, sans-serif; line-height: 150%; text-indent: -18pt;"><span style="line-height: 150%;">The
trick for giving bookmarks using Adobe Acrobat – </span></b><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">Go
to the page where bookmark is to be given, select the hand tool and go exactly
to the title where the bookmark is to be given (it is to ensured that, no text
is visible above bookmark title) and select the text, press control + B, the
title automatically appears in the bookmark panel (if there are errors in
bookmark title due to misreading of software, correct it manually), right click
on title and press set destination, finally click on all the bookmarks and
check whether they are going to exact destination.</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">Hyper linking of texts to the
destination is to be ensured, wherever applicable.</span></li>
</ul>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;">Requirements
of Scanned Documents<o:p></o:p></span></span></b></div>
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<ul>
<li style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">It commonly happens that, clarity of
documents is not checked before submitting to the Agency. </span><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">If we are not able to read a document due
to lack of clarity, we definitely cannot expect the reviewer to read the document.</span></li>
<li style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-align: justify; text-indent: -18pt;">The probability of Plant Layouts lacking
clarity is more. Hence, clearly scanned Plant Layouts should be submitted.</span></li>
<li style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-align: justify; text-indent: -18pt;">Please refer the below table for
scanning resolution requirements –</span></li>
</ul>
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</v:imagedata></v:shape></span><span style="line-height: 150%;"> </span><b><span style="line-height: 150%;">Image Courtesy: Portable
document format specifications guidance of USFDA</span></b><span style="line-height: 150%;"><o:p></o:p></span></span></div>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;"> </span></span></b></div>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;"> Leaf
Title Naming (for eCTD XML)</span></span></b></div>
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<ul>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">The Leaf Title should be elaborate,
considering ICH M4, M4Q guidelines, without the use of hyphens (-), full stops
(.).</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">Abbreviations should not be used.</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-align: justify; text-indent: -18pt;">Examples of Correct and Incorrect Naming
of eCTD Leaf Titles are provided below –</span><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-align: justify; text-indent: -18pt;">Correct Naming – Description and Composition
of the Drug Product </span><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-align: justify; text-indent: -18pt;">Incorrect Naming – desc-comp-dp</span></li>
</ul>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;">Note
–</span></span></b></div>
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<ul>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">The above post could also be considered
for NDA submissions.</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">I have listed the most important aspects
which are to be considered to avoid eCTD Deficiencies. Please refer the below references
for complete information related to eCTD.</span></li>
<li><span style="font-family: "arial" , "helvetica" , sans-serif; line-height: 150%; text-indent: -18pt;">For submissions with clinical data, “Study
Tagging Files” requirements are also to be considered.</span></li>
</ul>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;">References<o:p></o:p></span></span></b></div>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;"><a href="http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm333969.pdf">http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm333969.pdf</a><o:p></o:p></span></span></b></div>
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<b><span style="line-height: 150%;"><span style="font-family: "arial" , "helvetica" , sans-serif;"><a href="http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf">http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf</a><o:p></o:p></span></span></b></div>
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<span style="font-family: "arial" , "helvetica" , sans-serif;"><b><span style="line-height: 150%;"><a href="http://www.fda.gov/downloads/Drugs/UCM320405.pdf">http://www.fda.gov/downloads/Drugs/UCM320405.pdf</a></span></b>
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Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com90tag:blogger.com,1999:blog-7538891640847716324.post-51272234628966152152013-03-03T00:31:00.000+05:302013-10-26T22:10:54.827+05:30GDUFA AND ITS CONSEQUENCES<div dir="ltr" style="text-align: left;" trbidi="on">
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<o:p><span style="font-family: inherit;"><br /></span></o:p></div>
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<b style="text-align: justify;"><i><span style="font-family: inherit;">History and background of GDUFA:</span></i></b></div>
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<ul style="text-align: left;">
<li style="text-align: justify;"><span style="font-family: inherit; text-indent: -0.25in;">The one hundred twelfth congress of the United States
of America at the second session on 3</span><sup style="font-family: inherit; text-indent: -0.25in;">rd</sup><span style="font-family: inherit; text-indent: -0.25in;"> January, 2012, amended the
Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs
for prescription drugs and medical devices, to establish user-fee programs for
generic drugs and biosimilars and for other purposes.</span></li>
</ul>
<ul style="text-align: left;">
<li style="text-align: justify;"><span style="font-family: inherit; text-indent: -0.25in;"> T</span><span style="font-family: inherit; text-indent: -0.25in;">his act may be cited as the “Food and Drug Administration
Safety and Innovation Act”.</span></li>
</ul>
<ul style="text-align: left;">
<li><span style="font-family: inherit; text-align: justify; text-indent: -0.25in;"> </span><span style="font-family: inherit; text-align: justify; text-indent: -0.25in;">The amendment
is referred to as Generic Drug User Fee Amendments of 2012 (GDUFA).</span></li>
</ul>
<ul style="text-align: left;">
<li><span style="font-family: inherit; text-align: justify;"> </span><span style="font-family: inherit; text-align: justify; text-indent: -0.25in;">On July 9,
2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law. </span></li>
</ul>
<ul style="text-align: left;">
<li><span style="font-family: inherit; text-align: justify;"> </span><span style="font-family: inherit; text-align: justify; text-indent: -0.25in;">On Oct. 1,
2012, FDA implemented the Generic Drug User Fee Amendments of 2012 (GDUFA) </span></li>
</ul>
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<br /></div>
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<b><i><span style="font-family: inherit;">What is GDUFA and why was it implemented by FDA?</span></i></b></div>
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<ul>
<li style="text-align: justify;"><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">GDUFA is
Generic Drug User Fee Amendments of 2012 (GDUFA). GDUFA was implemented to speed
the delivery of safe and effective generic drugs to the public and reduce costs
to industry.</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">Under GDUFA,
certain facilities, sites, and organizations must self-identify and may be
Subject to user fees.</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">GDUFA
requires industry to pay user fees, which will supplement the costs of
reviewing generic drug applications and inspecting facilities.</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">The money
earned by FDA through GDUFA will help FDA to reduce a current backlog of
pending applications, cut the average time required to review generic drug
applications for safety, and increase risk- based inspections.</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">GDUFA is
designed to build on the success of the Prescription Drug User Fee Act (PDUFA).
Over the past 20 years, PDUFA has ensured a more predictable, consistent,
and streamlined premarket program for industry and helped speed access to new,
safe and effective prescription drugs for patients. </span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="color: windowtext;"><span style="font-family: inherit;"> </span></span><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">GDUFA
will also enhance global supply chain safety by requiring that generic drug
facilities and sites around the world self-identify. </span></li>
</ul>
<b style="font-family: inherit; text-align: justify;"><i><span style="color: windowtext;"></span></i></b><br />
<div>
<b style="font-family: inherit; text-align: justify;"><i><span style="color: windowtext;"><b style="font-family: inherit; text-align: justify;"><i><span style="color: windowtext;"><br /></span></i></b></span></i></b></div>
<b style="font-family: inherit; text-align: justify;"><i><span style="color: windowtext;">
Self-Identification: </span></i></b><span style="color: windowtext; font-family: inherit; text-align: justify;"> All the facilities which manufacture, or
intend to manufacture, human generic drug APIs or FDFs, or both are required to
self-identify. Under GDUFA, </span><span style="font-family: inherit; text-align: justify;">Self</span><span style="color: windowtext; font-family: inherit; text-align: justify;">-identification
is necessary to determine the universe of facilities required to pay user fees,
and is a central component of an effort to promote global supply chain
transparency. This information will enable quick, accurate, and reliable
surveillance of generic drugs and facilitate inspections and compliance.</span><br />
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<div class="Default" style="text-align: justify;">
<span style="color: windowtext;"><span style="font-family: inherit;">The Facilities/ Entities/Sites/ Organizations which are not required
to pay annual facility fee -<o:p></o:p></span></span></div>
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<ul>
<li style="text-align: justify;"><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">Generic
entities that solely manufacture positron emission tomography (PET) drugs</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">Clinical
bioequivalence or bioavailability study sites</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">In vitro
bioequivalence testing or bioanalytical testing sites</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">Active
pharmaceutical ingredient (API)/finished dosage form (FDF) analytical testing
sites</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="color: windowtext; font-family: inherit; text-indent: -0.25in;">Packagers and repackagers.</span></li>
</ul>
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<span style="font-family: inherit;"><b><i><span style="color: windowtext;"><br /></span></i></b></span></div>
<div class="Default" style="text-align: justify;">
<span style="font-family: inherit;"><b><i><span style="color: windowtext;">Penalty for failure to self-identify: </span></i></b>All FDFs (Finished dosage forms) or
APIs (Active Pharmaceutical Ingredients) manufactured in the facility, and all
FDFs containing APIs manufactured in the facility will be deemed misbranded. This
means that it will be a violation of federal law to ship these products in
interstate commerce or to import them into the United States.</span></div>
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<b><i><span style="color: windowtext;"><span style="font-family: inherit;"><br /></span></span></i></b></div>
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<b><i><span style="color: windowtext;"><span style="font-family: inherit;">GDUFA Fees</span></span></i></b></div>
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<span style="color: windowtext; font-family: inherit;">As stated in the earlier
section of this post, user fees have to be paid by the industry to supplement costs
of reviewing generic drug applications and inspecting facilities.</span></div>
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<span style="color: windowtext; font-family: inherit;"><br /></span></div>
<div class="Default" style="text-align: justify;">
<span style="color: windowtext; font-family: inherit;">The various types of GDUFA fees,
which were effective on October 1</span><sup style="color: windowtext; font-family: inherit;">st</sup><span style="color: windowtext; font-family: inherit;"> 2012, are listed below-</span></div>
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<b style="font-family: inherit;"><i><span style="color: windowtext;">Back log Fee</span></i></b><span style="color: windowtext; font-family: inherit;">- The ANDA, that has not been withdrawn,
which has been under review, got tentative approval, that was submitted as on September
28<sup>th</sup>, 2012 is considered for back log fee. The FDA calculated the
fee as <b>$17,434</b>.</span></div>
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<span style="color: windowtext; font-family: inherit;"><br /></span></div>
<div class="Default" style="text-align: justify;">
<b style="font-family: inherit;"><i><span style="color: windowtext;">DMF Fee- </span></i></b><span style="color: windowtext; font-family: inherit;">The Type II active
pharmaceutical ingredient (API) DMF that is referenced, on or after Oct. 1,
2012, in a generic drug submission by an initial letter of authorization (LOA) is
considered for DMF fee. The DMF fee For Year 2013 is calculated as <b>$21,340</b>. It is a one-time fee for each
individual DMF, incurred on first reference of the DMF on or after </span>Oct. 1, 2012<span style="color: windowtext; font-family: inherit;">..</span></div>
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<span style="color: windowtext; font-family: inherit;"><br /></span></div>
<div class="Default" style="text-align: justify;">
<b style="font-family: inherit;"><i>ANDA and PAS Fee</i></b><span style="font-family: inherit;">- The ANDA which is filed with FDA on or after October 1</span><sup style="font-family: inherit;">st</sup><span style="font-family: inherit;">,
2012 is considered for ANDA fee. The ANDA fee for year </span><span style="color: windowtext; font-family: inherit;">2013 is calculated as <b>$51,520. </b></span><span style="font-family: inherit;">PAS fee</span><span style="color: windowtext; font-family: inherit;"> is considered for any approved ANDA for which Prior Approval
Supplement (PAS) [PAS is filed to notify and seek approval of FDA for any major
change in an approved ANDA] is filed.</span><span style="font-family: inherit;"> The PAS fee for year </span><span style="color: windowtext; font-family: inherit;">2013 is calculated as <b>$25,760.
</b>The PAS fee is half the fee of new ANDA</span></div>
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<span style="font-family: inherit;"><span style="color: windowtext;"> </span><o:p></o:p></span></div>
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<b><i><span style="font-family: inherit;"><br /></span></i></b></div>
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<b><i><span style="font-family: inherit;">FDA’s Refuse to File Policy with respect to
GDUFA<o:p></o:p></span></i></b></div>
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<ul>
<li style="text-align: justify;"><span style="font-family: inherit;">GDUFA adds a new
requirement to FDA’s existing refuse to receive policy with respect to payment
of fees and the time of receipt of an ANDA.</span></li>
</ul>
<ul>
<li style="text-align: justify;"><o:p><span style="font-family: inherit;"> </span></o:p><span style="font-family: inherit; text-indent: -0.25in;">Failure to pay an ANDA fee within 20 calendar
days of the applicable due date will result in the ANDA not being received.</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="font-family: inherit; text-indent: -0.25in;">Failure to pay the fee for a DMF referenced in the
ANDA within 20 calendar days of the date that FDA provides notification of that
failure will result in the ANDA not being received.</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="font-family: inherit; text-indent: -0.25in;">Failure to pay a facility fee for any facility
referenced in the ANDA within 20 calendar days of the date that FDA provides
notification of that failure will result in the ANDA not being received.</span></li>
</ul>
<ul>
<li style="text-align: justify;"><span style="font-family: inherit; text-indent: -0.25in;">If an application is substantially complete
except for failure to pay the ANDA fee, or the failure to pay the facility fee
within 20 days of notification, the application will be deemed received as of
the date the fee is paid.</span></li>
</ul>
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<b><i><span style="font-family: inherit;"><br /></span></i></b></div>
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<b><i><span style="font-family: inherit;">My Take on GDUFA:</span></i></b></div>
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<span style="font-family: inherit;">The landmark
Hatch and Waxman act paved the way for fast track approval of generics in USA, which
resulted in large scale entry of generic players into the market over a period
of time. The presence of generics was
kind of, win-win situation for Government, Insurance companies and patients alike,
as generics resulted in saving billions of dollars to them. </span></div>
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<span style="font-family: inherit;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: inherit;">The numbers of
ANDAs filed are rapidly growing, which were around 900 in the year 2011. The numbers
of ANDAs pending for review were about 2600 in the year 2011. So, obviously it made the
job tough for FDA. Hence, the fees earned will help the FDA to increase its
resources and expedite the approval process of ANDAs.</span></div>
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<span style="font-family: inherit;"><br /></span></div>
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<span style="font-family: inherit;">The GDUFA may superficially
seem to be burdensome for generic companies. However, for the generic companies
which are serious to have their ANDA approval in the fact track and gain market
share as soon as possible, the GDUFA is positive news. </span></div>
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<span style="font-family: inherit;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: inherit;">Five years
down the line after implementation of GDUFA, the FDA has given commitment that,
it will review and act on 90 percent of complete electronic ANDAs within 10
months after the date of submission. This is fantastic news, as the generic
companies could get their ANDAs approved within 10 months of their filing for conventional
generic drugs. </span></div>
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<b><i><span style="font-family: inherit;">References –</span></i></b></div>
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<a href="http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf"><span style="color: blue; font-family: inherit;">http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf</span></a></div>
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<a href="http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm337385.htm"><span style="color: blue; font-family: inherit;">http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm337385.htm</span></a></div>
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<a href="http://www.fda.gov/AboutFDA/WorkingatFDA/GenericDrugUserFeeHiring/default.htm"><span style="color: blue; font-family: inherit;">http://www.fda.gov/AboutFDA/WorkingatFDA/GenericDrugUserFeeHiring/default.htm</span></a></div>
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<a href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM328354.pdf"><span style="color: blue; font-family: inherit;">http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM328354.pdf</span></a></div>
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<a href="http://www.gpo.gov/fdsys/pkg/FR-2012-10-25/pdf/2012-26256.pdf"><span style="color: blue; font-family: inherit;">http://www.gpo.gov/fdsys/pkg/FR-2012-10-25/pdf/2012-26256.pdf</span></a></div>
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<a href="http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm316678.htm"><span style="color: blue; font-family: inherit;">http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm316678.htm</span></a></div>
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<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM316671.pdf"><span style="color: blue; font-family: inherit;">http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM316671.pdf</span></a></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: inherit;"><a href="http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM296451.pdf">h<span style="color: blue;">ttp://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM296451.pdf</span></a></span></div>
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</div>
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<a href="http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm"><span style="color: blue;">http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm</span></a></div>
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<b><i>Cheers,</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>Rajesh Yelugoila</i></b></div>
</div>
Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com148tag:blogger.com,1999:blog-7538891640847716324.post-73020881117070644672012-10-02T02:29:00.001+05:302013-05-26T18:19:09.587+05:30How to get a job in the field of Regulatory Affairs ?<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh9JXWgcaILcz47ttXuM0_JvkSfvy_4rBiqiWE_5IwpIMY1DjRtR8COkmbEbSId-gAo8SkuR63Yc6pokCLvxqPT5L-Whv51kLSemuGe6heNfj7o-FLktXAtT876qO33OomghGw12efSdPjI/s1600/HW+TO.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em; text-align: center;"><img border="0" height="235" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh9JXWgcaILcz47ttXuM0_JvkSfvy_4rBiqiWE_5IwpIMY1DjRtR8COkmbEbSId-gAo8SkuR63Yc6pokCLvxqPT5L-Whv51kLSemuGe6heNfj7o-FLktXAtT876qO33OomghGw12efSdPjI/s400/HW+TO.bmp" width="400" /></a></div>
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<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;"><span style="font-size: small;">This article is aimed at listing down the simple steps/facts, which I hope will
help in solving the big riddle of getting a job in the field of regulatory
affairs !<o:p></o:p></span></span></div>
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<br /></div>
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<span style="font-family: inherit;">First of all, I would
like to share my personal experiences in pursuit of job in the field
of Regulatory Affairs. After my B.Pharmacy, I was pretty much sure that I
wanted to get into RA., so I enrolled into the course offered by BII-Industry Program
in RA, which was famous back then. I also enrolled into a short term industry
oriented course for pharma graduates which included RA as one of the topics. I
had also began researching regarding RA on the internet, but could get info in
bits and pieces (This was the reason for me to start Regulatory One). <o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="margin-bottom: 0pt; text-align: justify;">
<span style="font-family: inherit;">After considerable time
of enrolling into the above courses, I got a call for interview in my first
company. I had few more freshers (beginners) for competition at the time of
interview. I cleared the interview and got the job due to the fact that I had
done suitable home work and my research study on DMF (Drug Master files), which
was part of my course, was of great help. I am trying to state the fact that,
if you want to get a job, you need to have special skills which are not there
with your competitors!<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0pt; text-align: justify;">
<br /></div>
<div class="MsoNormal" style="margin-bottom: 0pt; text-align: justify;">
<span style="font-family: inherit;">The information which I
learnt, while I worked on Regulatory One, helped me to get my 2nd job.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0pt; text-align: justify;">
<br /></div>
<div class="MsoNormal" style="margin-bottom: 0pt; text-align: justify;">
<span style="font-family: inherit;"><b><i><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #222222;">Gaining Skills in Regulatory Affairs - </span><o:p></o:p></i></b></span></div>
<div style="text-align: justify;">
<ul type="disc">
<li class="MsoNormal"><span style="font-family: inherit;"><i><b>If you have done
M.pharmacy (not in RA)</b></i><i>-</i> My suggestion would be-do a
diploma/PG diploma course related to RA through
part-time/distance. My personally preferred course and institute is <span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #222222;">PG Diploma in
Pharmaceutical Regulatory Affairs from </span> Jamia
Hamdard University since it is <span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #222222;">accredited by NAAC in 'A' category and
they have contact classes in major cities. The feed back I received
regarding the course was that, its good.</span></span></li>
</ul>
</div>
<ul style="text-align: left;">
<li><div class="MsoNormal">
<span style="font-family: inherit;"><b><i><span style="background-color: white; background-position: initial initial; background-repeat: initial initial;">If you are </span></i><i>B. Pharmacy graduate and want to make a career
in RA</i></b><i> -</i>I would recommend you to do M.Pharmacy in
Pharmaceutical RA .</span>
</div>
</li>
</ul>
<div class="MsoNormal" style="text-align: justify;">
The list of institutes offering M.Pharmacy in RA are given in the below link.</div>
<div class="MsoNormal" style="text-align: justify;">
<span style="color: blue;"> </span><a href="http://www.regulatoryone.com/2011/10/institutes-offering-regulatory-affairs_03.html"><span style="color: blue;">http://www.regulatoryone.com/2011/10/institutes-offering-regulatory-affairs_03.html</span></a></div>
<div class="MsoNormal" style="text-align: justify;">
<ul>
<li> <span style="font-family: inherit;">Browse, through the websites of
Regulatory Agencies like FDA, MHRA, CDSCO and try to gain as much
knowledge as possible. In the below page of Regulatory One, Link to the
updated news section in the websites of premier regulatory agencies of
world is provided. </span></li>
</ul>
</div>
<span style="color: blue;"><span style="font-family: inherit; text-align: left;"> </span><a href="http://www.regulatoryone.com/p/updated-news.html" style="font-family: inherit; text-align: left;"><span style="color: blue;">http://www.regulatoryone.com/p/updated-news.html</span></a></span><br />
<ul type="disc">
<li class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">In FDA's website there are
links like <a href="http://www.fda.gov/Training/ForHealthProfessionals/default.htm"><span style="color: blue;">CDER learn</span></a> , <a href="http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm235225.htm"><span style="color: blue;">Educational Resources</span></a> and <a href="http://www.fda.gov/Drugs/ucm273272.htm"><span style="color: blue;">Webinars</span></a> which
contain lots of useful information. Similarly there are training modules
in MHRA' s website.Of course, all the above listed useful links are
absolutely free to access !<o:p></o:p></span></li>
</ul>
<ul type="disc">
<li class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Among all the ICH guidelines- <a href="http://www.ich.org/products/ctd.html"><span style="color: blue;">M4</span></a> (and
allied guidelines M4Q, M4S, M4S), <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf"><span style="color: blue;">Q1A</span></a> , <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1E/Step4/Q1E_Guideline.pdf"><span style="color: blue;">Q1E</span></a> ,<a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf"><span style="color: blue;">Q2</span></a>, <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3A_R2/Step4/Q3A_R2__Guideline.pdf"><span style="color: blue;">Q3A</span></a>, <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2__Guideline.pdf"><span style="color: blue;">Q3B</span></a>, <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Step4/Q3C_R5_Step4.pdf"><span style="color: blue;">Q3C</span></a>, <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf"><span style="color: blue;">Q6A</span></a> are the most important references
for RA professionals. Knowing them is very important.</span><span style="font-family: inherit;"> </span></li>
</ul>
<ul type="disc">
<li class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Go through all the articles,
which I have written in Regulatory One. I personally believe that, if a
beginner goes to the interview after reading the articles that I have
written, they could easily clear the interview.<o:p></o:p></span></li>
</ul>
<ul type="disc">
<li class="MsoNormal" style="text-align: left;"><span style="font-family: inherit;">The below listed link is very
useful at the time of interview, especially for beginners (freshers). </span></li>
</ul>
<span style="color: blue;"> <span style="color: blue;"><a href="http://www.regulatoryone.com/p/regulatory-affairs-interview-questions.html">http://www.regulatoryone.com/p/regulatory-affairs-interview-questions.html</a></span><br />
</span><br />
<i><b>Writing Skills -</b></i><br />
<ul>
<li>For a Regulatory Affairs professional, having good writing skills is very important, since he/she is involved in compilation of dossiers, responding to queries from regulatory agencies. </li>
</ul>
<i style="font-weight: bold;">Resume - </i><br />
<ul>
<li>Make sure that, you have a well formatted, unique resume which is different from others. If possible, get the resume reviewed by an expert. Ensure to highlight the course which you have done related to RA and specific skill with respect to RA.</li>
<li>Upload your resume in job websites like Monster and Naukri. Ensure to fill up all your details and have a complete profile.</li>
</ul>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<div class="separator" style="clear: both; text-align: center;">
<br /></div>
<span style="font-family: inherit;"><i><b>Networking</b> - </i> Networking
is an important tool for getting to know about any openings in the field of
Regulatory Affairs. In the professional Networking sites like Linkedin, having
your complete profile is very important. The following things are to be
considered/taken note of, while setting up your profile-<o:p></o:p></span></div>
<ul type="disc">
<li class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Have your detailed profile,
with special emphasis on your educational qualification, skills related to
regulatory affairs. <o:p></o:p></span></li>
</ul>
<ul type="disc">
<li class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Ensure that the information is
given in a properly structured manner, without any grammatical errors.<o:p></o:p></span></li>
</ul>
<ul type="disc">
<li class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Ensure that the photo which you
have uploaded is a one in which you are in formal dress and definitely not
the one, which you had taken during your vacation in a casual dress!<o:p></o:p></span></li>
</ul>
<ul type="disc">
<li class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Join groups related to
Regulatory Affairs like Drug Regulatory Affairs, Global Regulatory
Affairs, Regulatory Affairs Job Opportunities etc and take
active part in discussions in a relevant way.<o:p></o:p></span></li>
</ul>
<ul type="disc">
<li class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Request people who are in
senior positions in RA field to be part of your Networks. If they accept
to be part of your network, send them an email,(in a
properly structured manner, without any
typo/grammatical errors) requesting them to let you know if there are
any openings in their company. Respect their privacy, and do not ask them
for their personal numbers. If they see your profile and
they find you to be good enough, they may definitely let you
know, if there are any openings.<o:p></o:p></span></li>
</ul>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<span style="font-family: inherit;"><i><span style="background-color: white; background-position: initial initial; background-repeat: initial initial;"><b><span style="color: #222222;">General Misconceptions</span>- </b></span></i></span><span style="background-color: white; color: #222222; font-family: inherit;">I
guess, some of you might have got the free advice- "Start of your career
by working in Quality Control /Quality Assurance. Then you will have a better
chance of getting a job in RA". This logic is absolute false. Why will a
company prefer a person with experience in QC/QA over a person with experience
in RA ?</span></div>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<br /></div>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<span style="font-family: inherit;"><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #222222;">Guys,
a person who is a fresher (beginner) can get a job in RA. The best example is,
myself !</span><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<br /></div>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<span style="font-family: inherit;"><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #222222;">Hope,
the above article will help you in getting a job in the field of
Regulatory Affairs. </span><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<br /></div>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<span style="font-family: inherit;"><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #222222;">Best
of Luck! </span><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<br /></div>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<span style="font-family: inherit;"><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #222222;">P.S-</span><o:p></o:p></span></div>
<ul type="disc">
<li class="MsoNormal"><span style="font-family: inherit;"><span style="background-color: white; background-position: initial initial; background-repeat: initial initial; color: #222222;">The above article is intended, mainly for the people from India, who are interested to make a career in
the field of RA.</span><o:p></o:p></span></li>
</ul>
<ul type="disc">
<li class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><span style="color: #222222;">I am not in a
position where I could refer/recommend for a job. So, kindly do not email
me your resumes.</span><o:p></o:p></span></li>
</ul>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<br /></div>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<span style="font-family: inherit;"><br /></span></div>
<ul type="disc">
</ul>
<div class="MsoNormal" style="margin-bottom: 0pt;">
<br /></div>
<br /></div>
Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com88tag:blogger.com,1999:blog-7538891640847716324.post-1384093216436386692012-03-23T01:55:00.004+05:302012-03-24T00:00:33.960+05:30GRASE, Grandfathered and DESI Drugs<div dir="ltr" style="text-align: left;" trbidi="on"><br />
<div class="MsoNormal" style="margin-bottom: 8pt;"></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiW1UvTm91kvl2A4JRECpZdJCX-s0t9Ij7KuBhq8oV9CzbXZ7PLftZMPm9_xGRs4GgqXnuNfeSTMFojS9HbIQLwdUSIV8manzhwACFPY30z38Ek_G1YpKLUZSZZtAhY3Qgz49Et_cG1KORr/s1600/logo.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="257" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiW1UvTm91kvl2A4JRECpZdJCX-s0t9Ij7KuBhq8oV9CzbXZ7PLftZMPm9_xGRs4GgqXnuNfeSTMFojS9HbIQLwdUSIV8manzhwACFPY30z38Ek_G1YpKLUZSZZtAhY3Qgz49Et_cG1KORr/s400/logo.bmp" width="400" /></a></div><div class="MsoNormal" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><b><i>GRASE</i></b> <b><i>Drugs</i></b>-</span></div><div class="MsoNormal" style="text-align: justify;"></div><ul><li style="text-align: justify;"><span style="font-family: inherit;">The abbreviation of the term GRASE is -<b>Generally Recognized as Safe and Effective</b></span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">GRASE Drugs are certain old drugs that do not require prior approval from FDA in order to be marketed because they are generally recognized as safe and effective based on published scientific literature.</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">It is not an easy standard for a drug to qualify as GRASE. For a drug to qualify under the category of GRASE, it has to fulfill the following criteria-</span></li>
</ul><ol style="text-align: left;"><li><span style="font-family: inherit; text-align: justify;">The Drug must have been subjected to adequate and well controlled clinical investigations that established its safety and effective.</span></li>
<li style="text-align: justify;"><span style="font-family: inherit;">The Investigation results must be published in the scientific literature so that they are available to qualified experts.</span></li>
<li style="text-align: justify;"><span style="font-family: inherit;">Experts must generally agree, based on those published studies, that the drug is safe and effective for its intended uses.</span></li>
</ol><ul style="text-align: left;"><li><span style="font-family: inherit; text-align: justify;">A product's general recognition as safe and effective must be demonstrated by at least the same quality and quantity of data necessary to support FDA approval for marketing.</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">It is unlikely that any currently marketed prescription drug is GRASE.</span></li>
</ul><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><b><i>Note:</i></b> The term GRAS (Generally Recognized as Safe) was used in 1938, Federal Food, Drug, and Cosmetic act.</span></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">The term GRASE (Generally Recognized as Safe and Effective) was used in 1962 amendment to the Federal Food, Drug, and Cosmetic act.</span></div><div class="MsoNormal" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><b><i>Grandfathered Drugs</i></b>- </span></div><div class="MsoNormal" style="text-align: justify;"></div><ul><li style="text-align: justify;"><span style="font-family: inherit;">Drugs that entered the market before the passage of the 1938 act or the 1962 amendments to the act are often referred to as grandfathered drugs.</span></li>
<li style="text-align: justify;"><span style="font-family: inherit;">Under the 1962 grandfather clause, the FFDCA exempts a drug from the effectiveness requirements if its composition and labeling have not changed since 1962 and if, on the day before the 1962 amendments became effective, it was</span></li>
</ul><ol style="text-align: left;"><li><span style="font-family: inherit; text-align: justify;"> Used or sold commercially in the United States</span></li>
<span style="font-family: inherit;">
<li style="text-align: justify;"><span style="font-family: inherit;"> Not a new drug as defined by the act at that time</span></li>
<li style="text-align: justify;"><span style="font-family: inherit;"> Not covered by an effective application</span></li>
</span></ol><span style="font-family: inherit; text-align: justify;"><ul><li><span style="font-family: inherit;">Many older drugs without FDA approval claim to be grandfathered; however, FDA believes that very few drugs are on the market that are actually entitled to grandfather status because the drugs currently on the market likely differ from the previous versions in some respect, such as formulation, dosage or strength, dosage form, route of administration, indications, labeling, or intended patient population.</span></li>
</ul></span><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><b><i>DESI Drugs</i></b>-<span style="font-size: 9pt;"> </span></span></div><div class="MsoNormal" style="text-align: justify;"></div><ul><li><span style="font-size: small;">The abbreviation of term</span><b style="font-size: medium;"> </b><span style="font-size: small;">DESI is</span><b style="font-size: medium;">- </b><b><span style="font-family: inherit;">Drug Efficacy Study Implementation</span></b></li>
</ul><ul><li><span style="font-family: inherit;">Drugs that entered the US market between 1938 and 1962 and that were approved for safety but not effectiveness are referred to as </span><i style="font-family: inherit;">DESI drugs.</i>.<span style="font-family: MyriadPro-Regular, sans-serif; font-size: 9pt;"> </span>Drugs that are IRS (Identical related or Similar ) to such drugs are also called DESI drugs.</li>
</ul><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: inherit;">Background-<o:p></o:p></span></i></b></div><div class="MsoNormal" style="text-align: justify;"></div><ul><li style="text-align: justify;"><span style="font-family: inherit;">“Safety” was the criteria for the approval of New Drugs between the passage of 1938, Federal Food, Drug, and Cosmetic act and its amendment in 1962 (<span class="apple-converted-space"><span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial;"> </span></span><span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial;">Kefauver-Harris amendment</span>).</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">“Safety and Efficacy criteria“had to be met as per the Kefauver-Harris amendment for the approval of New Drugs. </span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">The <span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial;">Kefauver-Harris amendment</span> also required that FDA evaluate the safety and the effectiveness of new drugs marketed between 1938 and 1962.</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;"><b>Drug Efficacy Study Implementation</b> (<b>DESI</b>) was a program begun by the Food and Drug Administration (FDA) after the requirement by<span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial;"> Kefauver-Harris amendment that all drugs marketed between 1938 and 1962 be safe and effective.</span></span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">The Drug Efficacy Study Implementation (DESI) evaluated over 3000 separate products and over 16,000 therapeutic claims.</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">By 1984, final action had been completed on 3,443 products; of these, 2,225 were found to be effective, 1,051 were found not effective, and 167 were pending.</span></li>
</ul><div><b style="font-style: italic;">Keywords- </b>Federal Food, Drug and Cosmetic act (FFDCA)-1938, <span style="background-color: white;">Kefauver-Harris amendment-1962.</span> </div><div><br />
</div><div><b><i>References-</i></b></div><div>1<span style="color: blue;">.<a href="http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074382.htm"><span style="color: blue;">http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074382.htm</span></a> </span><b><i><br />
</i></b></div><div>2.<span style="color: blue;"><a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm119899.pdf"><span style="color: blue;">http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm119899.pdf</span></a> </span></div><div>3.<span style="color: blue;"><a href="http://fdadrugcompliance.com/docs/Course.pdf"><span style="color: blue;">http://fdadrugcompliance.com/docs/Course.pdf</span></a> </span></div><div>4. <span style="color: blue;"><a href="http://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementation"><span style="color: blue;">http://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementation</span></a> </span></div><br />
<br />
</div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com39tag:blogger.com,1999:blog-7538891640847716324.post-17169739758287218952012-03-08T01:29:00.116+05:302012-03-19T13:57:52.945+05:30CEP<div dir="ltr" style="text-align: left;" trbidi="on"><div style="font-family: inherit; text-align: justify;"></div><div class="separator" style="clear: both; font-family: inherit; text-align: center;"></div><div class="MsoNormal" style="font-family: inherit; text-align: justify;"><span style="font-size: small;"><br />
</span></div><div class="separator" style="clear: both; font-family: inherit; text-align: center;"><span style="font-size: small;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEglP_oEanSfPT92Nzrjp0gzn5HKlWrmJ_jPuaMCcTsAy0sWV53MYUzKQ39DrmX4VGrhUlNtrpcR67rHcJDRP8VPx-SXv1OfEs_vWjk-m8GKKB0j-xkYDw4Zy_PT9NWIyxvbK9is6kGBgzti/s1600/logo.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="252" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEglP_oEanSfPT92Nzrjp0gzn5HKlWrmJ_jPuaMCcTsAy0sWV53MYUzKQ39DrmX4VGrhUlNtrpcR67rHcJDRP8VPx-SXv1OfEs_vWjk-m8GKKB0j-xkYDw4Zy_PT9NWIyxvbK9is6kGBgzti/s400/logo.bmp" width="400" /></a></span></div><div class="MsoNormal" style="font-family: inherit; text-align: justify;"><span style="font-size: small;"><br />
</span></div><div class="MsoNormal" style="font-family: inherit; text-align: justify;"><span style="font-size: small;"><br />
</span></div><div class="MsoNormal" style="font-family: inherit; text-align: justify;"><span style="font-size: small;"><b><i>What is the Full form of abbreviation, CEP?</i></b></span></div><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><div class="MsoNormal" style="font-family: inherit; text-align: justify;"><span style="font-size: small;">Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs </span></div><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><div class="MsoNormal" style="font-family: inherit; text-align: justify;"><span style="font-size: small;">It is also informally referred to as Certificate of Suitability (COS)</span></div><div class="MsoNormal" style="font-family: inherit; text-align: justify;"><span style="font-size: small;"><br />
</span></div><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><div class="MsoNormal" style="font-family: inherit; text-align: justify;"><span style="font-size: small;"><b><i>What is a CEP?</i></b></span></div><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><div class="MsoNormal" style="font-family: inherit; text-align: justify;"><span style="font-size: small;">It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.</span></div><div class="MsoNormal" style="font-family: inherit; text-align: justify;"><span style="font-size: small;"><br />
</span></div><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><b><i>For which substances, applications for the grant of CEPs can be submitted?</i></b></span></div><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;">Applications for the grant of CEPs can be submitted to EDQM if monograph (general monograph and/or specific monograph) has been adopted by the European Pharmacopoeia for the following-</span></div><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><ul style="font-family: inherit; text-align: justify;"><li><span style="font-size: small;">Organic or inorganic substances (active or excipients), manufactured or extracted.</span></li>
</ul><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><ul style="font-family: inherit; text-align: justify;"><li><span style="font-size: small;">Sterile Active Substances</span></li>
</ul><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><ul style="font-family: inherit; text-align: justify;"><li><span style="font-size: small;">Substances produced by fermentation as indirect gene products, which are metabolites of microorganisms, irrespective of whether or not the microorganisms have been modified by traditional procedures or r-DNA technology </span></li>
</ul><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><ul style="font-family: inherit; text-align: justify;"><li><span style="font-size: small;">Products with risk of transmitting agents of animal spongiform encephalopathies (TSE) </span></li>
</ul><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><ul style="font-family: inherit; text-align: left;"><li><span style="font-size: small;">Herbal Drugs and Herbal Drug Preparations</span></li>
</ul><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><b><i>For which substances CEP is not granted?</i></b></span></div><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><ul style="font-family: inherit; text-align: justify;"><li><span style="font-size: small;">Direct gene products (proteins) </span></li>
</ul><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><ul style="font-family: inherit; text-align: justify;"><li><span style="font-size: small;">Products obtained from human tissues </span></li>
</ul><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><ul style="font-family: inherit; text-align: justify;"><li><span style="font-size: small;">Vaccines </span></li>
</ul><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><ul style="font-family: inherit; text-align: justify;"><li><span style="font-size: small;">Blood products and preparations.</span></li>
</ul><div style="font-family: inherit; text-align: justify;"><span style="font-size: small;"> </span></div><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><b><i>What are the Legislations which describe certification Procedure?</i></b></span></div><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><a href="http://www.edqm.eu/site/cep_procedure_revised_versionpdf-en-101-2.html" style="color: red;" title="CEP Procedure Revised Version AP-CSP (07) 1 E">Resolution AP-CSP (07) 1 on the 'Certification of Suitability to the Monographs of the European Pharmacopoeia (Revised Version)'</a><span style="color: red;"> <span style="color: black;">(</span></span>Adopted by the Public Health Committee (CD-P-SP) on 21/02/2007)</span></div><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;">Directives 2001/82/EC and 2001/83/EC, as amended, of the European Council and of the Parliament.</span></div><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><i><b>Guidelines to be referred for preparing Dossier to obtain a CEP </b></i></span><br />
<div style="background: none repeat scroll 0% 0% white; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small; line-height: 115%;"> </span> </div><span style="color: red; font-size: small; line-height: 115%;"><a href="http://www.edqm.eu/medias/fichiers/cep_content_of_the_dossier_for_chemical_purity_mic.pdf"><span style="color: red;">Content of the Dossier for Chemical Purity and Microbiological Quality (PA/PH/CEP 04 1 4R)</span></a></span></div><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><div style="background: none repeat scroll 0% 0% white; margin: 0in 0in 6pt; text-align: justify;"><span style="font-size: small;"><span style="color: red;"><a href="http://www.edqm.eu/site/cep_content_of_the_dossier_for_a_substance_for_tsepdf-en-779-2.html" title="CEP - Content of the Dossier for a Substance for TSE Risk Assessment"><span style="color: red;">Content of the Dossier for a Substance for <abbr lang="en" title="Transmissible spongiform encephalopathy">TSE</abbr> Risk Assessment (PA/PH/CEP (06) 2)</span></a></span></span></div><div style="background: none repeat scroll 0% 0% white; margin: 0in 0in 6pt; text-align: justify;"><span style="font-size: small;"><span style="color: red;"><a href="http://www.edqm.eu/site/cep_content_of_the_dossier_for_herbal_drugs_herbalpdf-en-217-2.html" title="CEP - Content of the Dossier for Herbal Drugs & Herbal Drugs Preparation Quality Evaluation"><span style="background-attachment: scroll; background-clip: initial; background-color: white; background-image: none; background-origin: initial; background-position: 0% 0%; background-repeat: repeat repeat; color: red;">Content of the Dossier for Herbal Drugs and Herbal Drug Preparation Quality Evaluation</span></a></span></span></div><div style="background: none repeat scroll 0% 0% white; margin: 0in 0in 6pt; text-align: justify;"><span style="font-size: small;"><span style="color: red;"><a href="http://www.edqm.eu/site/cep_for_sterile_active_substancespdf-en-30713-2.html" title="CEP - Certificates of suitability for sterile active substances PA/PH/Exp. CEP/T (06) 13, 1R"><span style="color: red;">Certificates of Suitability for Sterile Active Substances (PA/PH/Exp. CEP/T (06) 13, 1R)</span></a></span></span></div><div style="background: none repeat scroll 0% 0% white; margin: 0in 0in 6pt; text-align: justify;"><span style="font-size: small;"><span style="color: red;"><a href="http://www.edqm.eu/site/cep_clarification_on_the_acceptability_of_cep_applpdf-en-8143-2.html" title="CEP - Clarification on the acceptability of CEP applications for sterile grade material PA/PH/CEP (08) 60 "><span style="background-attachment: scroll; background-clip: initial; background-color: white; background-image: none; background-origin: initial; background-position: 0% 0%; background-repeat: repeat repeat; color: red;">Clarification on the Acceptability of <abbr lang="en" title="Certificate of suitability">CEP</abbr> </span><span style="color: red;">Applications for Sterile Grade Material (PA/PH/CEP (08) 60, November 2008)</span></a> </span></span></div><div style="background: none repeat scroll 0% 0% white; font-family: inherit; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><i><b><span style="color: black;">Note : </span></b></i></span><span style="font-size: small;"><span style="color: black;"> </span></span><br />
<span style="font-size: small;"><span style="color: black;">1. Each of the above guideline corresponds to individual type of substances. For example, the first Guideline is to be referred for preparing dossier to obtain a CEP for an API.</span></span></div><div style="font-family: inherit;"><span style="font-size: small;"> <span style="color: black; line-height: 115%;">2. Each of the above guideline is to be referred in conjunction with </span><span style="color: red; line-height: 115%;"><a href="http://www.edqm.eu/site/cep_procedure_revised_versionpdf-en-101-2.html" title="CEP Procedure Revised Version AP-CSP (07) 1 E"><span style="color: red;">Resolution AP-CSP (07) 1 on the 'Certification of Suitability to the Monographs of the European Pharmacopoeia (Revised Version)</span></a></span></span></div></div><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><div style="background: none repeat scroll 0% 0% white; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><b><i><span style="color: black;">Application form and template for QOS</span></i></b><span style="color: red;"> </span></span><br />
<span style="font-size: small;"><a href="http://www.edqm.eu/site/New-Applications-29.html"><span style="color: red;">Link for Downloading Application form and template of QOS.</span></a></span></div><div style="margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><b><i><span style="line-height: 115%;">Note</span></i></b><span style="line-height: 115%;">: Click on the hyperlinks in blue for application form and template of QOS to download them.</span><span style="color: red;"> </span></span></div><div style="margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><b><i>Online Database of Approved CEPs</i></b><span style="color: red;"><span style="color: red;"> </span></span></span><br />
<span style="font-size: small;"><span style="color: red;"><a href="https://extranet.edqm.eu/publications/recherches_CEP.shtml"><span style="color: red;">Link to Online Databases of Approved CEPs</span></a> </span></span></div><div style="margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><i><b><span style="color: black;">Registration Fees </span></b></i> </span><br />
<span style="color: red; font-size: small;"><a href="http://www.edqm.eu/medias/fichiers/cep_registration_fees_applicable_from_1_march_2010.pdf"><span style="color: red;">Registration fees for various New CEP Applications<i><b> </b></i></span></a></span><br />
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<span style="font-size: small;"><i><b><span style="color: red;"><span style="color: red;"><span style="color: black;"> Deficiencies</span></span></span></b></i></span><br />
<span style="font-size: small;"><i><b><span style="color: red;"><span style="color: red;"><span style="color: black;"> </span></span></span></b></i><a href="http://www.edqm.eu/medias/fichiers/cep_top_ten_deficiencies_new_applications.pdf" style="color: red;">Link to top 10 deficiencies in New Applications for grant of CEPs </a></span><br />
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<span style="font-size: small;"><b style="font-family: inherit;"><i><span style="color: black; line-height: 115%;">Recognition of CEPs- </span></i></b><span style="color: black; font-family: inherit; line-height: 115%;">CEPs are recognised by all the member countries of the European Union and also other Countries like Canada, Australia, New Zealand, Tunisia and Morocco.</span></span><span style="font-size: small;"><span style="font-family: inherit;"> </span></span><br />
<span style="font-size: small;"><span style="font-family: inherit;"> </span><i><b><span style="color: red;"><span style="color: red;"><span style="color: black;"> </span></span></span></b></i></span><br />
<span style="font-size: small;"><i><b><span style="color: red;"><span style="color: red;"><span style="color: black;">Advantages of CEPs-</span></span></span></b></i></span></div><ul><li><span style="font-size: small;"><span style="color: red;"><span style="color: red;"><span style="color: black;"> It is valid for 5 Years.</span></span></span></span></li>
<li><span style="font-size: small;"><span style="color: red;"><span style="color: red;"><span style="color: black;">An API manufacturer need not file an ASMF/EDMF in all the member countries involved in DCP/MRP Procedures if the manufacturer has obtained CEP for that specific API. Sending a Copy of CEP will do.</span></span></span></span></li>
<li><span style="font-size: small;"><span style="color: red;"><span style="color: red;"><span style="color: black;">Centralised evaluation of Dossier by only one agency i.e EDQM.</span></span></span></span></li>
</ul><span style="font-size: small;"><i><b><span style="color: red;"><span style="color: red;"><span style="color: black;">References-</span></span></span></b></i></span></div><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"><span style="color: red;"><span style="color: red;"><span style="color: black;"> 1<span style="color: red;">.</span></span></span></span><a href="http://www.edqm.eu/site/Background-Legal-Framework-77.html" style="color: red;">http://www.edqm.eu/site/Background-Legal-Framework-77.html</a></span></div><div class="MsoNormal" style="color: red; font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><span style="font-size: small;"> <span style="color: black;">2.</span><span style="color: red;"> </span><a href="http://www.edqm.eu/site/New-Applications-29.html#" style="color: red;">http://www.edqm.eu/site/New-Applications-29.html#</a></span></div><div class="MsoNormal" style="font-family: inherit; line-height: normal; margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit; font-size: small;"><i><b>Keywords: </b></i>CEP, EDQM,</span><span style="font-family: inherit; font-size: small;"> </span><span style="font-family: inherit; font-size: small;"> </span><span style="font-family: inherit; font-size: small;">Resolution AP-CSP (07) 1, </span><span style="font-family: inherit; font-size: small;">Directives 2001/82/EC and 2001/83/EC.</span></div><div style="font-family: inherit;"><span style="font-size: small;"> </span></div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com13tag:blogger.com,1999:blog-7538891640847716324.post-30140181828803571502012-02-20T23:38:00.010+05:302012-03-19T13:10:50.437+05:30Sample Quality Overall Summary<div dir="ltr" style="text-align: left;" trbidi="on"><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhC85QJV8nSyY3wEFZCfS3TKh2v-Hx86KGVFpIPXjJ85r-MXlVL5YCwxR8L_SgK-VWzz5AG1CrvPFu6ABG_fsXroiLXCcXaBDIHLCPhweKtYOnmonDx3v4XUKsYtQ9JiDvITDsz-j2H7SHs/s1600/logo.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="255" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhC85QJV8nSyY3wEFZCfS3TKh2v-Hx86KGVFpIPXjJ85r-MXlVL5YCwxR8L_SgK-VWzz5AG1CrvPFu6ABG_fsXroiLXCcXaBDIHLCPhweKtYOnmonDx3v4XUKsYtQ9JiDvITDsz-j2H7SHs/s400/logo.bmp" width="400" /></a></div><div style="text-align: justify;"><br />
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</div><div style="text-align: justify;">I am sure that, many of you may be interested to take a look at complete NDA/ANDA/Dossier/ASMF. Since, they contain confidential information, no company would like to share it in public domain. But guys! you could check out sample Quality Overall Summary (part of Module-2) of an ANDA submission. FDA has posted samples of Quality overall summary (QOS) in its website the links of which are provided below-</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><a href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm120979.pdf"><span style="color: red;">Sample Quality Overall Summary of ANDA submission for Ersatztine Tablets USP</span></a><br />
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<a href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm120977.pdf"><span style="color: red;">Sample Quality Overall Summary of ANDA submission for MK Controlled release Capsules</span></a></div><div style="text-align: justify;"><br />
Module 2- It is part of NDA/ANDA/Dossier/DMF/ASMF, where the summaries of Modules-3,4,5 are presented. It could be correlated to an abstract of research article or trailer of a movie! The module-2 (Common Technical Document Summaries) consist of the following sections-</div><div><div class="MsoNormal" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;">2.1 Common Technical Document Table of Contents (Modules 2-5) </div><div class="MsoNormal" style="text-align: justify;">2.2 CTD Introduction</div><div class="MsoNormal" style="text-align: justify;">2.3 Quality Overall Summary </div><div class="MsoNormal" style="text-align: justify;">2.4 Nonclinical Overview </div><div class="MsoNormal" style="text-align: justify;">2.5 Clinical Overview </div><div class="MsoNormal" style="text-align: justify;">2.6 Nonclinical Written and Tabulated Summaries </div><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;">Pharmacology</li>
<li style="text-align: justify;">Pharmacokinetics</li>
<li style="text-align: justify;">Toxicology</li>
</ul><div style="text-align: justify;">2.7 Clinical Summary</div><ul style="text-align: left;"><li><span style="text-align: justify;">Biopharmaceutic Studies and Associated Analytical Methods</span></li>
<li style="text-align: justify;">Clinical Pharmacology Studies</li>
<li style="text-align: justify;">Clinical Efficacy</li>
<li style="text-align: justify;">Clinical Safety</li>
<li style="text-align: justify;">Literature References</li>
<li style="text-align: justify;">Synopses of Individual Studies</li>
</ul><br />
<div class="MsoNormal" style="text-align: justify;"><o:p> As discussed by me earlier, you need to refer -<a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf"><span style="color: red;">M4 Guideline</span></a>, </o:p><a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf"><span style="color: red;">M4Q Guideline</span></a>, <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R2__Safety/M4S_R2_.pdf"><span style="color: red;">M4S Guideline</span></a>, <a href="http://www.blogger.com/goog_1844826664"><span style="color: red;">M4E Guideline</span></a><o:p><a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R1__Efficacy/M4E__R1_.pdf"> </a>to file a </o:p>NDA/ANDA/Dossier/DMF/ASMF in CTD format.</div><div class="MsoNormal" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><i><b>Reference-</b></i><a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf">M4 Guideline</a><br />
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<i><b>Keywords - </b></i>Sample Quality Overall Summary, Module-2, M4 Guideline, FDA.</div></div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com20tag:blogger.com,1999:blog-7538891640847716324.post-72683314285348318842012-02-14T18:32:00.012+05:302012-03-19T12:57:24.775+05:30Changes to an approved NDA or ANDA<div dir="ltr" style="text-align: left;" trbidi="on"><br />
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</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">In this post, I am going to discuss about the post approval changes and their reporting categories. After the approval of NDA or ANDA, the applicant may make post approval changes, provided the changes are reported to the FDA under the appropriate categories.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><a href="http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm109164.htm"><span style="color: red;">Section 506 A</span></a> of the Federal Food, Drugs and Cosmetics act and <a href="http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=314&SECTION=70&YEAR=1999&TYPE=PDF"><span style="color: red;">21 CFR 314.70</span></a> provide for 4 reporting categories of the post approval changes which are listed below-</span></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: left;"><span style="font-family: inherit;">1. Major Change </span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: left;"><span style="font-family: inherit;">2. Moderate Change- It is categorized into 2 types-</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: left;"><span style="font-family: inherit;"> (a) The change requiring the submission of <b><i>Supplement - Changes Being Effected in 30 Days</i></b> </span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: left;"><span style="font-family: inherit;"> (b) The change requiring the submission of <b><i>Supplement - Changes Being Effected</i></b> </span><br />
<span style="font-family: inherit;">3. Minor Change </span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: left;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg68BVLG3F8bKa-8XHXXcP7sH5ybax3dXWPNhBCzZWNepEi7gGp6VGvAeqCRCr5xuWevE2mfMbWEERLneEVvV84u71w_KzP-2eCSLWKwRkH0BHaphFwu7UNa6oh4m9y13KnYa-vT3tJYoBq/s1600/chart.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em; text-align: center;"><img border="0" height="216" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg68BVLG3F8bKa-8XHXXcP7sH5ybax3dXWPNhBCzZWNepEi7gGp6VGvAeqCRCr5xuWevE2mfMbWEERLneEVvV84u71w_KzP-2eCSLWKwRkH0BHaphFwu7UNa6oh4m9y13KnYa-vT3tJYoBq/s400/chart.bmp" width="400" /></a></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: left;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><b><i>1.</i></b> <b><i>Major Change-</i></b> </span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"></div><ul><li><span style="font-family: inherit;">A major change is a change that has a </span><b style="font-family: inherit;">substantial potential</b><span style="font-family: inherit;"> to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product.</span><span style="font-family: inherit;"> </span><span style="font-family: inherit;"> </span></li>
<li><span style="font-family: inherit;">A major change requires the submission of a supplement and approval by FDA prior to distribution of the drug product made using the change. This type of supplement is called and should be clearly labeled as </span><b style="font-family: inherit;"><i>Prior approval supplement</i></b><span style="font-family: inherit;">.</span></li>
</ul><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
<ul><li><span style="font-family: inherit;">An applicant may ask FDA to expedite its review of a prior approval supplement for public health reasons like drug shortage or in case if there is a delay would impose an extraordinary hardship on the applicant. </span></li>
</ul></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"> </span></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;"><b><i>2. Moderate Change- </i></b>A moderate change<b><i> </i></b>is a change that has a <b>moderate potential</b> to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.</span></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;">The moderate change is categorized into 2 types based on the type of supplement being filed - </span></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;"> <b><i>a) Supplement - Changes Being Effected in 30 Days</i></b></span></div><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">This type of change requires submission of supplement to FDA at least 30 days before the distribution of drug product made using the change. </span><span style="font-family: inherit;"> </span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">This type of supplement is called, and should be clearly labeled, a </span><b style="font-family: inherit;"><i>Supplement - Changes being effected in 30 Days.</i></b></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">The drug product made using moderate changes cannot be distributed if the FDA informs the applicant to file a prior approval supplement for the changes made or if FDA informs that the information is missing or if FDA disapproves the changes being affected in 30 days.</span></li>
</ul><br />
<div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"> <b><i>b) Supplement - Changes Being Effected<o:p></o:p></i></b></span></div><div class="MsoNormal" style="text-align: justify;"></div><ul><li><span style="font-family: inherit;">This type of supplement contains changes for which distribution can occur when FDA receives the supplement.</span></li>
</ul><ul><li><span style="font-family: inherit;">FDA may order the manufacturer to cease distribution of the drug products made using the disapproved change, If, after review, FDA disapproves a changes-being effected.</span></li>
</ul><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;"><b><i>3. Minor change</i></b> -A minor change<b><i> </i></b>is a change that has <b>minimal potential</b> to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product. <o:p></o:p></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;"> Assessing the effect of manufacturing changes<o:p></o:p></span></i></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;"><br />
</span></i></b></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;"><b><i>A. Assessment of the effects of the change-</i></b>The applicant<b><i> </i></b>must assess the effects of the change before distributing a drug product made with a manufacturing change. Assessment should be made on the following-</span></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><b><i>1. Conformance to specifications-</i></b> An assessment of the effects of a change on the identity, strength, quality, purity, and potency of the drug product should include a determination that the drug substance intermediates, drug substance, in-process materials, and/or drug product affected by the change conform to the approved specifications.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;">2. Additional Testing- </span></i></b><br />
<ul><li><span style="font-family: inherit;">Apart from checking for conformance to specifications, the applicant should perform additional testing, when appropriate, to assess whether the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product have been or will be affected.</span></li>
</ul><ul><li><span style="font-family: inherit;">The assessment should include, as appropriate, evaluation of any changes in the chemical, physical, microbiological, biological, bioavailability, and/or stability profiles.</span></li>
</ul><ul><li><span style="font-family: inherit;">This additional assessment could involve testing of the post change drug product itself or, if appropriate, the material directly affected by the change.</span></li>
<li><span style="font-family: inherit;">The type of additional testing that an applicant should perform would depend on the type of manufacturing change, the type of drug substance and/or drug product, and the effect of the change on the quality of the drug product.</span></li>
</ul></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">For Example-<span style="line-height: 115%;"> </span>Evaluation of the hardness or friability of a tablet after certain changes.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><b><i>B. Equivalence-</i></b> When testing is performed, the applicant should usually assess the extent to which the manufacturing change has affected the identity, strength, quality, purity, and potency of the drug product. Typically this is accomplished by comparing test results from pre- and post change material and determining if the test results are equivalent.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><b><i>C. Adverse Effects-</i></b><span style="line-height: 115%;"> </span>Some manufacturing changes have an adverse effect on the identity, strength, quality, purity, or potency of the drug product, which in most cases are not implemented by applicant. </span><span style="font-family: inherit;">If an assessment</span><b style="font-family: inherit;"><i> </i></b><span style="font-family: inherit;">indicates that a change has adversely affected the identity, strength, quality, purity, or</span><b style="font-family: inherit;"><i> </i></b><span style="font-family: inherit;">potency of the drug product, FDA recommends that the change be submitted in a prior</span><b style="font-family: inherit;"><i> </i></b><span style="font-family: inherit;">approval supplement regardless of the recommended reporting category for the</span><b style="font-family: inherit;"><i> </i></b><span style="font-family: inherit;">change.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">The reporting categories for the post approval changes are provided with respect to the following-<o:p></o:p></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"> (1) Components and composition</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"> (2) Manufacturing sites</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"> (3) Manufacturing process </span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"> (4) Specifications</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"> (5) Container closure system</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"> </span><span style="font-family: inherit;">(6) Labeling</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"> (7) Miscellaneous changes </span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"> (8) Multiple related changes</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="margin-bottom: 6.0pt; mso-layout-grid-align: none; text-align: justify; text-autospace: none; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;">(1) Components and composition-</span></i></b></div><div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;"><ul><li><span style="font-family: inherit;">Changes in the qualitative or quantitative formulation, including inactive ingredients, as provided in the approved application, are considered major changes requiring a prior approval supplement, unless exempted by regulation or guidance.</span></li>
<li><span style="font-family: inherit;">The deletion or reduction of an ingredient intended to affect only the color of the drug product may be reported in an annual report.</span></li>
</ul></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;">(2) Manufacturing sites<o:p></o:p></span></i></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;"><br />
</span></i></b></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><i><span style="font-family: inherit;">Example under reporting category of major change (Prior approval supplement)- <b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;">A move to a different manufacturing site, except one used to manufacture or process a drug substance intermediate, when the new manufacturing site has never been inspected by FDA for the type of operation that is being moved or the move results in a restart at the new manufacturing site of a type of operation that has been discontinued for more than two years.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of moderate change (supplement changes being effected in 30 days)-</span></i><br />
A move to a different manufacturing site for the primary packaging of (1) any drug product that is not otherwise listed as a major change and (2) modified-release solid oral dosage form drug products.</div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of moderate change (supplement changes being effected)-<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="line-height: 115%;"><span style="font-family: inherit;">Move to a different manufacturing site for the manufacture or processing of the final intermediate.<o:p></o:p></span></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="line-height: 115%;"><span style="font-family: inherit;"><br />
</span></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category Minor Changes (Annual Report)<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">A move to a different manufacturing site for secondary packaging.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><b><i>(3) Manufacturing process</i></b></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><b><i><br />
</i></b></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of major change (Prior approval supplement)-</span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">Changes that may affect the controlled (or modified) release, metering or other characteristics (e.g., particle size) of the dose delivered to the patient, including the addition or deletion of a code imprint by embossing, debossing, or engraving on a modified-release solid oral dosage form.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><i>Example under reporting category of moderate change (supplement changes being effected in 30 days)- </i></span><br />
<span style="font-family: inherit;">For Drug substance, redefinition of an intermediate, excluding the final material, as the starting material.<i> </i></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of moderate change (supplement changes being effected)-</span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">A change in methods or controls that provides increased assurance that the drug substance or drug product will have the characteristics of identity, strength, quality, purity, or potency that it purports or is represented to possess.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of minor Changes (Annual Report) <b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">A minor change in an existing code imprint for a dosage form. For example, changing from a numeric to alphanumeric code.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;">(4) Specifications<o:p></o:p></span></i></b><br />
<b><i><span style="font-family: inherit;"><br />
</span></i></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of major change (Prior approval supplement)-<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Establishing a new regulatory analytical procedure including designation of an alternative analytical procedure as a regulatory procedure.</span></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of moderate change (supplement changes being effected in 30 days)-<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;">Relaxing an acceptance criterion or deleting a test to comply with an official compendium that is consistent with FDA statutory and regulatory requirements<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of moderate change (supplement changes being effected)-<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">An addition to a specification that provides increased assurance that the drug substance or drug product will have the characteristics of identity, strength, quality, purity, or potency that it purports or is represented to possess. For example, adding a new test and associated analytical procedure and acceptance criterion</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">.</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of minor Changes (Annual Report) <b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;">Tightening of acceptance criteria.</span><b><i><o:p></o:p></i></b></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;"><br />
</span></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;">(5) Container closure system</span></i></b><br />
<b><i><span style="font-family: inherit;"><br />
</span></i></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of major change (Prior approval supplement)-<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;">A change in the primary packaging components for any drug product when</span><b><i> </i></b><span style="line-height: 115%;">the primary packaging components control</span><span style="line-height: 115%;"> </span><span style="line-height: 115%;">the dose delivered to the</span><b><i> </i></b><span style="line-height: 115%;">patient (e.g., the valve or actuator of a metered-dose inhaler).</span><b><i><o:p></o:p></i></b></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;"><br />
</span></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of moderate change (supplement changes being effected in 30 days)-<b> </b></span></i><br />
Changes in the size or shape of a container for a sterile drug substance.</div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of moderate change (supplement changes being effected)-<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;">A change in or addition or deletion of a desiccant.</span><b><i><o:p></o:p></i></b></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;"><br />
</span></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of minor Changes (Annual Report) <b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;">A change in the size and/or shape of a container for a nonsterile solid dosage form<o:p></o:p></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;">(6) Labeling<o:p></o:p></span></i></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;"><br />
</span></i></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of major change (Prior approval supplement)-<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Changes based on postmarketing study results, including, but not limited to, labeling changes associated with new indications and usage.</span></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of moderate change (supplement changes being effected)-<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;">Addition of an adverse event due to information reported to the applicant or Agency.<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of minor Changes (Annual Report) <b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;">Labeling changes made to comply with an official compendium.</span><b><i><o:p></o:p></i></b></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;"><br />
</span></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;">(7) Miscellaneous changes <o:p></o:p></span></i></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;"><br />
</span></i></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of major change (Prior approval supplement)-<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;">Addition of a stability protocol or comparability protocol</span><b><i><o:p></o:p></i></b></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;"><br />
</span></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of moderate change (supplement changes being effected in 30 days)-<b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Reduction of an expiration dating period to provide increased assurance of the identity, strength,quality, purity, or potency of the drug product. Extension of an expiration date that has previously been reduced under this provision should be submitted in a changes-being-effected-in-30-days supplement even if the extension is based on data obtained under a protocol approved in the application.</span></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><i>Example under reporting category of moderate change (supplement changes being effected)-</i><span style="line-height: 115%;"> No changes have been identified.</span><b><i><o:p></o:p></i></b></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"><span style="line-height: 115%;"><br />
</span></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><span style="font-family: inherit;">Example under reporting category of minor Changes (Annual Report) <b><o:p></o:p></b></span></i></div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: inherit;">An extension of an expiration dating period based on full shelf life data on production batches obtained under a protocol approved in the application<o:p></o:p></span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i><span style="font-family: inherit;">(8) Multiple related changes<o:p></o:p></span></i></b><br />
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</span></i></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">For multiple related changes where the recommended reporting categories for the individual changes differ, CDER recommends that the submission be in accordance with the most restrictive of the categories recommended for the individual changes. When the multiple related changes all have the same recommended reporting category, CDER recommends that the submission be in accordance with the reporting category for the individual changes.</span><br />
<span style="font-family: inherit;"><b><i><br class="Apple-interchange-newline" />Note- </i></b>View the guidance-</span><a href="http://www.fda.gov/OHRMS/DOCKETS/98fr/1999d-0529-gdl0003.pdf"><span style="color: red;">Changes to an approved NDA or ANDA</span></a><span style="font-family: inherit;"> for </span>categorization<span style="font-family: inherit;"> of all the possible changes.</span><br />
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<div class="MsoNormal"><b style="font-family: inherit;"><i>Reference-</i></b></div><div class="MsoNormal"><span style="font-family: inherit;"><a href="http://www.fda.gov/OHRMS/DOCKETS/98fr/1999d-0529-gdl0003.pdf">Changes to an approved NDA or ANDA</a></span><br />
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</div><div class="MsoNormal"><b><i>Further reading-</i></b><br />
<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122871.pdf">Changes to an approved NDA or ANDA Questions and Answers</a><br />
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<i><b><span style="font-family: inherit;">Keywords: </span></b></i><span style="font-family: inherit;">Changes to an approved NDA or ANDA, Section 506A, 21 CFR 314.70, Major Changes, Moderate Change, Supplement-Changes being effected in 30 Days, Supplement -Changes being effected, Minor Change.</span></div></div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com20tag:blogger.com,1999:blog-7538891640847716324.post-1744300370821419572012-02-07T13:45:00.001+05:302012-02-07T13:57:25.673+05:30European Medicines Agency - 15th Anniversary Corporate Video<div dir="ltr" style="text-align: left;" trbidi="on"><iframe allowfullscreen="" frameborder="0" height="270" src="http://www.youtube.com/embed/Js6Pjqd43oU?fs=1" width="480"></iframe></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com11tag:blogger.com,1999:blog-7538891640847716324.post-28315545043423961462012-01-24T00:12:00.007+05:302013-06-16T13:47:10.144+05:30Abbreviated New Drug Application (ANDA)<div dir="ltr" style="text-align: left;" trbidi="on">
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<span style="font-family: inherit;"><b><i>What is an ANDA?</i></b></span></div>
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<span style="font-family: inherit;">An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.</span></div>
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<span style="font-family: inherit;"><b><i>In simple words</i></b> “It is an application which is filed with USFDA for generic drug approval <span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial;">of an existing </span>licensed medication or approved drug<span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial;">.”<o:p></o:p></span></span></div>
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<span style="font-family: inherit;"><b><i>A generic drug product</i></b> is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.<o:p></o:p></span></div>
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<b><i><span style="font-family: inherit;">I. Important facts about generics and generic drug applications (ANDA)-</span></i></b></div>
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<li style="text-align: justify;"><span style="font-family: inherit;">Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. </span></li>
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<li style="text-align: justify;"><span style="font-family: inherit;"> </span><span style="font-family: inherit;">Generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). </span></li>
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<li style="text-align: justify;"><span style="font-family: inherit;">Bioequivalence is generally determined by measuring the time taken for generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. This gives the rate of absorption, or bioavailability, of the generic drug, which can be compared to that of the innovator drug. </span></li>
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<li style="text-align: justify;"><span style="font-family: inherit;">The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug</span><span style="font-family: inherit;">. </span></li>
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<li style="text-align: justify;"><span class="apple-converted-space" style="font-family: inherit;"> The </span><span style="font-family: inherit;">basis for approving generic copies of drug products was established by the "</span><span style="font-family: inherit;"><b><i>Drug Price Competition and Patent Term Restoration Act of 1984</i></b></span><span style="font-family: inherit;">," also known as the "<b><i>Hatch -Waxman Act"</i>.</b></span><span class="apple-converted-space" style="font-family: inherit;"><b> </b></span></li>
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<span style="font-family: inherit;"><b><i>II. Facility and Drug Registration for filing an ANDA-</i></b><o:p></o:p></span></div>
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<li class="MsoNormal" style="margin-bottom: 6.0pt; mso-list: l4 level1 lfo1; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;"> The facility should be registered with FDA using form FDA 2656(Registration of Drug Establishment/Labeler Code Assignment form).<o:p></o:p></span></li>
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<li class="MsoNormal" style="margin-bottom: 6.0pt; mso-list: l0 level1 lfo2; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">The product(s)/Drugs to be listed with FDA using form FDA 2657 (Drug listing form) .<o:p></o:p></span></li>
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<span style="font-family: inherit;">Note: From June 1, 2009 FDA is accepting only electronic submissions of forms FDA 2656 and 2657.</span></div>
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<span style="font-family: inherit;"><b><i>III.Format and content of ANDA-</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;">The FDA recommends ICH’s CTD for filing the ANDA.<o:p></o:p></span></div>
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Documents in each Module<o:p></o:p></div>
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<b>Module<o:p></o:p></b></div>
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<b>Information<o:p></o:p></b></div>
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1<o:p></o:p></div>
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Administrative and prescribing information (region specific)<o:p></o:p></div>
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2</div>
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Summaries and overview</div>
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3<o:p></o:p></div>
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Information on product quality<o:p></o:p></div>
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4<o:p></o:p></div>
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Nonclinical study reports<o:p></o:p></div>
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5<o:p></o:p></div>
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Clinical study reports<o:p></o:p></div>
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<span style="font-family: inherit;"><b><i>Module 1- Administrative and prescribing information</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;">Documents should be organized in the order listed below. Generally, all of the documents in Module 1 can be provided in a single volume. Environmental assessments should be submitted separately.<o:p></o:p></span></div>
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<b><i><span style="font-family: inherit;">1. Forms and cover letter-<o:p></o:p></span></i></b></div>
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<li style="text-align: justify;"><span style="font-family: inherit; line-height: 115%; text-indent: -0.25in;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> <span style="color: red;"> </span></span></span><span style="font-family: inherit; text-indent: -0.25in;"><a href="http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM082348.pdf"><span style="color: red;">FDA form 356h</span></a></span></li>
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<li style="text-align: justify;"><span style="font-family: inherit; line-height: 115%; text-indent: -0.25in;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="font-family: inherit; text-indent: -0.25in;">Cover letter</span></li>
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<li style="text-align: justify;"><span style="font-family: inherit; line-height: 115%; text-indent: -0.25in;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="font-family: inherit; text-indent: -0.25in;"><a href="http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048364.pdf"><span style="color: red;">Form FDA 3674</span></a></span></li>
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<span style="font-family: inherit;"><b><i>2. Comprehensive table of contents</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;">The next document in Module 1 should be the comprehensive table of contents for the entire submission. Each ANDA submission is required to have a comprehensive table of contents or index for the entire submission (as per <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.94"><span style="color: red;">21 CFR 314.94</span></a>)<o:p></o:p></span></div>
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<span style="font-family: inherit;"><b><i>3. Administrative documents</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;"><b><i>a. Administrative documents</i></b><o:p></o:p></span></div>
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<li class="MsoNormal" style="margin-bottom: 6.0pt; mso-list: l3 level1 lfo4; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">Appropriate administrative documents should be provided with the submission. Examples of administrative documents are listed below. <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.94"><span style="color: red;">21 CFR 314.94</span> </a> consists of details on the administrative documents needed for ANDA.<o:p></o:p></span></li>
<li><span style="font-family: inherit; text-align: justify;">Field copy certification</span></li>
<li><span style="font-family: inherit; text-align: justify;">Debarment certification</span></li>
<li><span style="font-family: inherit; text-align: justify;">Financial Certification</span></li>
<li><span style="font-family: inherit; text-align: justify;"> Patent information on any patent that claims the drug, if applicable</span></li>
<li><span style="font-family: inherit; text-align: justify;">Patent certifications</span></li>
<li><span style="font-family: inherit; text-align: justify;">Letters of authorization for reference to other applications or drug master files (if applicable)</span></li>
<li><span style="font-family: inherit; text-align: justify;">US Agent Letter of Authorization</span></li>
<li><span style="font-family: inherit; text-align: justify;">Proprietary name request (if applicable )</span></li>
<li><span style="font-family: inherit; text-align: justify;">Basis of ANDA submission</span></li>
<li><span style="font-family: inherit; text-align: justify;">Comparison between Generic Drug and RLD-505(j)(2)(A)</span></li>
<li><span style="font-family: inherit; text-align: justify;">Request for waiver</span></li>
<li><span style="font-family: inherit; text-align: justify;">Draft labeling</span></li>
<li><span style="font-family: inherit; text-align: justify;">Listed drug labeling</span></li>
<li><span style="font-family: inherit; text-align: justify;">Labeling requirements</span></li>
<li><span style="font-family: inherit; text-align: justify;">Financial disclosure information</span></li>
<li><span style="font-family: inherit; text-align: justify;">Waiver requests</span></li>
<li><span style="font-family: inherit; text-align: justify;">Environmental assessment or request for categorical exclusion</span></li>
<li><span style="font-family: inherit; text-align: justify;">Statements of claimed exclusivity and associated certifications</span></li>
</ul>
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<span style="font-family: inherit;">*Environmental assessment should be provided as a separate volume.<o:p></o:p></span></div>
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<span style="font-family: inherit;"><b><i>b.Prescribing information</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;">All copies of the labels and all labeling for the product should be included. Examples are provided below-<o:p></o:p></span></div>
<ul style="margin-top: 0in;" type="disc">
<li class="MsoNormal" style="margin-bottom: 6.0pt; mso-list: l2 level1 lfo5; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">Container and package labels<o:p></o:p></span></li>
<li class="MsoNormal" style="margin-bottom: 6.0pt; mso-list: l2 level1 lfo5; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">Package inserts<o:p></o:p></span></li>
<li class="MsoNormal" style="margin-bottom: 6.0pt; mso-list: l2 level1 lfo5; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">Draft labeling<o:p></o:p></span></li>
<li class="MsoNormal" style="margin-bottom: 6.0pt; mso-list: l2 level1 lfo5; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">Patient leaflets<o:p></o:p></span></li>
<li class="MsoNormal" style="margin-bottom: 6.0pt; mso-list: l2 level1 lfo5; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">Information sheets<o:p></o:p></span></li>
<li class="MsoNormal" style="margin-bottom: 6.0pt; mso-list: l2 level1 lfo5; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: inherit;">Medication Guides<o:p></o:p></span></li>
</ul>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<b><i><span style="font-family: inherit;">c. Labeling comparison<o:p></o:p></span></i></b></div>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;">For the ANDA, the comparison of labeling should be provided that is described in<span style="color: red;"> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.94"><span style="color: red;">21 CFR 314.94(a)(8).</span></a></span><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;"><b><i>Module 2 – Common Technical Document Summaries</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;"> Module 2 should include the summary documents. The documents for this module should be provided in the order as described below.<o:p></o:p></span></div>
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<span style="font-family: inherit;"><b><i>1. Overall CTD table of contents</i></b><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;">For the first document in this module, a comprehensive table of Contents should be provided listing all of the documents provided in the submission for modules 2 through 5.</span></div>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;"><b><i>2. Introduction to the summary documents</i></b><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;">Introduction to the summary should be provided as described in the guidance document <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf"><span style="color: red;">M4: Organization of the CTD</span></a> as a one page document.<o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;"><b><i>3. Overviews and summaries</i></b><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;">Module 2 should contain the following additional documents as described in the appropriate guidance documents (<a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf"><span style="color: red;">M4Q: The CTD -Quality</span></a>, <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R2__Safety/M4S_R2_.pdf"><span style="color: red;">M4S:The CTD - Safety</span></a>, <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R1__Efficacy/M4E__R1_.pdf"><span style="color: red;">M4E: The CTD – Efficacy</span></a>):</span></div>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<ul>
<li><span style="font-family: inherit;">Quality overall summary (2.3, Module 2, section 3)</span></li>
<li><span style="font-family: inherit;">Non clinical overview (2.4)</span></li>
<li><span style="font-family: inherit;">Clinical overview (2.5)</span></li>
<li><span style="font-family: inherit;">Nonclinical summary (2.6)</span></li>
<li><span style="font-family: inherit;">Clinical summary (2.7)</span></li>
</ul>
</div>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;">The nonclinical summary and the clinical summary should be provided in separate volumes for ease of use by reviewers.<o:p></o:p></span></div>
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</div>
<div class="MsoNormal">
<span style="text-align: left;"><b><i>Module 3 - Quality</i></b></span></div>
<div class="MsoNormal">
Module 3 should include information on the drug and product that should be provided in the order described below</div>
<br />
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;"><b><i>1. Module 3 table of contents</i></b><o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;">The first document in this module should be a table of contents listing all of the documents provided for module 3. See the guidance document <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf"><span style="color: red;">M4Q: The CTD Quality</span></a> for the headings and order to be used in the table of contents, including numbering of section headings.<o:p></o:p></span></div>
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<span style="font-family: inherit;"><b><i>2. Body of data</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;">Each individual subsection related to the drug and product should be provided as an individual document either bound separately or divided by tab identifiers, depending on the size of the subsection. The documents should be presented in the order in which they are listed in the table of contents.<o:p></o:p></span></div>
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<span style="font-family: inherit;"><b><i>3. Literature References</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;">Each literature reference should be provided as an individual document, separated from the others by tab identifiers.<o:p></o:p></span></div>
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<span style="font-family: inherit;"><b><i>Module 4 - Nonclinical Study Reports</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;">For an ANDA submission Module 4 is not necessary.</span></div>
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<br /></div>
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<span style="font-family: inherit;"><b><i>Module 5 - Clinical Study Reports</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;">Module 5 should contain clinical study reports and related information. The documents for this module should be provided in the order described below.<o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;"><br />
</span></div>
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<span style="font-family: inherit;"><b><i>1. Module 5 table of contents</i></b><o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;">The first document in this module should be a table of contents listing all of the documents provided in Module 5. See the guidance to industry <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R1__Efficacy/M4E__R1_.pdf"><span style="color: red;">M4E: The CTD – Efficacy</span></a> for the headings and order to be used in the table of contents, including numbering of section headings.<o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;"><br />
</span></div>
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;"><b><i>2. Study reports and related information</i></b><o:p></o:p></span></div>
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<span style="font-family: inherit;">Each study report and each related document should be provided , such as tabular listings of all clinical studies, as an individual document separated from the other documents by binders or tab dividers. Tab identifiers be provided for each appendix in a study report. These documents should be presented in the order in which they are listed in the table of contents.<o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;"><br />
</span></div>
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<span style="font-family: inherit;"><b><i>3. Literature References</i></b><o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;">Each literature reference should be provided as an individual document separated from the others by tab identifiers.<o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">
<span style="font-family: inherit;"> For information in module 5 specific to an ANDA, refer -<span style="color: red;"><a href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM151259.pdf"><span style="color: red;">ANDA filing checklist</span></a>.</span></span><br />
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<b><i>V. Number of Copies of ANDA</i></b>- The regulations requires archival, review, and field copies of ANDAs</div>
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<b><i>1.Archival Copy</i></b>- The archival copy is a complete copy of the application. It serves as the official archive of the application and may be used during the review of the application.</div>
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</div>
<div class="MsoNormal" style="margin-bottom: 6.0pt;">
<b><i>2. Review copy</i></b>- It includes the information needed by each review discipline for its evaluation. These copies facilitate the concurrent review of the application by the different review disciplines. Review copies that may be necessary according to 21 CFR 314.94 for an individual submission include:</div>
<div class="MsoNormal" style="margin-bottom: 6.0pt;">
Quality (Module 3),</div>
<div class="MsoNormal" style="margin-bottom: 6.0pt;">
Clinical (Module 5) – Bioequivalence documents</div>
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Copy of Modules 1 and 2 should be provided in each review copy. Each review copy should be labeled and bound separately.</div>
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<br /></div>
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</div>
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<b><i>3. Field copy</i></b>-The field copy should be a separately bound copy of the Quality section (Module 3) for the ANDA.</div>
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<b><i>VI. Paper size, font size, pagination, binder colors and mailing address-</i></b></div>
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Paper size-Standard U.S. letter size paper (8.5 x 11 inches) should be used for all submissions.</div>
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Font size-Narrative text be submitted in Times New Roman 12 point font. Font sizes 9 to10 points are considered acceptable in tables.</div>
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Pagination-Page numbering should be at the document level and not at the volume or module level. (The entire submission should never be numbered consecutively by page.) In general, all documents should have page numbers. Since the page numbering is at the document level, there should only be one set of page numbers for each document.</div>
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<b><i>Binder Colors for ANDA Copies</i></b></div>
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<table border="0" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="border-collapse: collapse; mso-padding-alt: 0in 0in 0in 0in; mso-yfti-tbllook: 1184;"><tbody>
<tr> <td style="border: solid black 1.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.2in;" valign="top" width="115"><div class="MsoNormal" style="margin-bottom: 6.0pt;">
<b><i>copy <o:p></o:p></i></b></div>
</td> <td style="border-left: none; border: solid black 1.0pt; mso-border-left-alt: solid black 1.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 153.0pt;" valign="top" width="204"><div class="MsoNormal" style="margin-bottom: 6.0pt;">
<b><i>Binder color<o:p></o:p></i></b></div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-top-alt: solid black 1.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.2in;" valign="top" width="115"><div class="MsoNormal" style="margin-bottom: 6.0pt;">
Archival Copy<o:p></o:p></div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; width: 153.0pt;" valign="top" width="204"><div class="MsoNormal" style="margin-bottom: 6.0pt;">
Blue<o:p></o:p></div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-top-alt: solid black 1.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.2in;" valign="top" width="115"><div class="MsoNormal" style="margin-bottom: 6.0pt;">
Review Copy<o:p></o:p></div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; width: 153.0pt;" valign="top" width="204"><div class="MsoNormal" style="margin-bottom: 6.0pt;">
Red<o:p></o:p></div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-top-alt: solid black 1.0pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.2in;" valign="top" width="115"><div class="MsoNormal" style="margin-bottom: 6.0pt;">
Field Copy<o:p></o:p></div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; padding: 0in 5.4pt 0in 5.4pt; width: 153.0pt;" valign="top" width="204"><div class="MsoNormal" style="margin-bottom: 6.0pt;">
Green<o:p></o:p></div>
</td> </tr>
</tbody></table>
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<b><i>Mailing Address for Abbreviated New Drug Applications (ANDAs)</i></b><o:p></o:p></div>
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Office of Generic Drugs (HFD-600)<o:p></o:p></div>
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Center for Drug Evaluation and Research<o:p></o:p></div>
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Food and Drug Administration<o:p></o:p></div>
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Metro Park North VII<o:p></o:p></div>
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7620 Standish Place<o:p></o:p></div>
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Rockville, MD 20855 </div>
<span style="font-family: inherit;"><span style="color: red;"><br />
</span></span></div>
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<div style="text-align: center;">
<b><span style="font-size: large;"> ANDA REVIEW PROCESS</span></b></div>
<div style="text-align: center;">
<b><span style="font-size: large;"><br />
</span></b></div>
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<b><span style="font-size: large;"><br />
</span></b><br />
<div style="text-align: center;">
<b><span style="font-size: large;"> NDA and ANDA REQUIREMENTS</span></b></div>
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<div class="separator" style="clear: both; text-align: left;">
<span style="color: red;"> <a href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM151259.pdf"><span style="color: red;">LINK FOR ANDA CHECKLIST</span></a></span></div>
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<br /></div>
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<b><i>References-</i></b></div>
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1. <a href="http://en.wikipedia.org/wiki/Abbreviated_New_Drug_Application" style="text-align: justify;">http://en.wikipedia.org/wiki/Abbreviated_New_Drug_Application</a></div>
<div class="separator" style="clear: both; text-align: left;">
2.<a href="http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm" style="text-align: justify;">http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm</a></div>
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3.<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073308.pdf" style="text-align: justify;">http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073308.pdf</a></div>
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4.<a href="http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm" style="text-align: justify;">http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm</a></div>
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5.<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073276.pdf" style="text-align: justify;">http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073276.pdf</a></div>
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6.<a href="http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM226568.pdf" style="text-align: justify;">http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM226568.pdf</a></div>
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7.<a href="http://www.fda.gov/downloads/Drugs/NewsEvents/UCM167310.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=generic%20drug%20review%20process&utm_content=5" style="text-align: justify;">http://www.fda.gov/downloads/Drugs/NewsEvents/UCM167310.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=generic%20drug%20review%20process&utm_content=5</a></div>
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<b style="font-style: italic; text-align: justify;">Keywords: </b><span style="text-align: justify;">ANDA, Generic Drug, OGD, </span><span style="text-align: justify;">form FDA 2656, <span style="font-family: inherit;"><span style="line-height: 17px;">Form FDA 2657, </span></span></span><span style="font-family: Symbol; font-size: 10pt; line-height: 115%; text-align: justify; text-indent: -0.25in;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="text-align: justify; text-indent: -0.25in;">FDA form 356h, </span><span style="font-family: Symbol; font-size: 10pt; line-height: 115%; text-align: justify; text-indent: -0.25in;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="text-align: justify; text-indent: -0.25in;">Form FDA 3674, 21 CFR 314.94, CTD.</span></div>
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<span style="background-color: white; color: #222222; font-family: Arial, Tahoma, Helvetica, FreeSans, sans-serif; font-size: 13px; line-height: 18px; text-align: justify;">1.This article is intended to provide guidance only for filing paper format of ANDA.</span> <br />
<span style="background-color: white; color: #222222; font-family: Arial, Tahoma, Helvetica, FreeSans, sans-serif; font-size: 13px; line-height: 18px; text-align: justify;">2. Part of the article is based on Draft Guidance.</span><br />
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Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com59tag:blogger.com,1999:blog-7538891640847716324.post-20267482603890973892012-01-19T13:03:00.003+05:302012-03-19T13:01:05.407+05:30Tools for Understanding Drug Regulatory Process in USA<div dir="ltr" style="text-align: left;" trbidi="on"><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh8vQ8oAbvXie5jtS1kFf4umdARzv9d5Q9KyLNYjXRdpM6SiB7KWrXwIHDCX9cWQFIF16GzRCA15pgBbU9ZY_TblEwQo-FtBGN_vPxc8-ctPqL5LL14nxypYo95cmDyUo2BuThZMj_o5yUj/s1600/logo.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="255" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh8vQ8oAbvXie5jtS1kFf4umdARzv9d5Q9KyLNYjXRdpM6SiB7KWrXwIHDCX9cWQFIF16GzRCA15pgBbU9ZY_TblEwQo-FtBGN_vPxc8-ctPqL5LL14nxypYo95cmDyUo2BuThZMj_o5yUj/s400/logo.bmp" width="400" /></a></div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">At the onset of New Year, 2012 I was pleasantly surprised to see a new look of FDA's website where the browsing through the contents was a pleasure. You may be wondering, why I post many articles related to Drug Regulatory Process in USA ? Understanding Drug regulatory process in USA is a easy task , thanks to the various tutorials and tools offered by FDA and its affiliated websites. In this post I will give the links in FDA and its affiliated website where we could get useful tools for understanding Drug Regulatory Process in USA.<br />
<br />
The tools and resources are as follows<span style="color: red;">-</span></div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">1.<span style="color: red;"> </span><a href="http://www.fda.gov/Training/ForHealthProfessionals/default.htm"><span style="color: red;">CDER Learn</span></a><br />
<i><b>CDER Learn has the following course list-</b></i></div><ul style="text-align: left;"><li style="text-align: justify;">CDER World</li>
</ul><ul><li style="text-align: justify;">The Past, Present, and Future of FDA Human Drug Regulation</li>
</ul><ul><li style="text-align: justify;">Bringing an Unapproved Drug Into Compliance </li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit; line-height: 17px;">Risk assessment and communication</span></li>
</ul><ul><li style="text-align: justify;">FDA Medwatch and Patient Safety </li>
</ul><ul><li style="text-align: justify;">Field Investigators: Adverse Drug Effects (ADE) Investigators (2000)</li>
</ul><ul><li style="text-align: justify;">The FDA Process for Approving Generic Drugs <a href="http://www.blogger.com/post-edit.g?blogID=7538891640847716324&postID=2026748260389097389" name="genericdrugs"> </a></li>
</ul><ul><li style="text-align: justify;">An Introduction to the Improved FDA Prescription Drug Labeling <a href="http://www.blogger.com/post-edit.g?blogID=7538891640847716324&postID=2026748260389097389" id="labeling" name="labeling"> </a></li>
</ul><div class="MsoNormal" style="margin-bottom: 4pt;"></div><div class="MsoNormal" style="margin-bottom: 4pt;"></div><div class="MsoNormal" style="margin-bottom: 4pt;"></div><div class="MsoNormal" style="margin-bottom: 4pt;"><div style="text-align: justify;">2.<span style="color: red;"> <a href="http://fdadrugcompliance.com/"><span style="color: red;">FDA Drug Compliance</span></a></span></div></div><div class="MsoNormal" style="margin-bottom: 4pt;"></div><ul><li style="text-align: justify;">The website <a href="http://fdadrugcompliance.com/">http://fdadrugcompliance.com/</a> mainly talks about bringing an unapproved Drug into compliance, various approval pathways.</li>
</ul><ul><li style="text-align: justify;">The courses are taught through a video interface .</li>
</ul><ul><li style="text-align: justify;">There is also a knowledge check section .</li>
</ul><div><div style="text-align: justify;">3. <a href="http://www.fda.gov/Drugs/ResourcesForYou/Industry/default.htm"><span style="color: red;">Information for Industry (Drugs)</span></a></div></div><div><div style="text-align: justify;">This section provides the resources related to drugs, ranging from the guidances , types of applications, drug approvals and databases etc.</div></div><div><div style="text-align: justify;"><br />
</div></div><div><div style="text-align: justify;">4. <a href="https://blogs.fda.gov/fdavoice/"><span style="color: red;">FDA Voice</span></a></div></div><div><div style="text-align: justify;">This is a recent addition to the FDA's website where the FDA's senior leadership and staff write regarding various current topics of interest.</div></div><div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">Hence, I believe there is no point in wasting money for buying books and other resources for understanding Drug Regulatory Process in the USA. Of course, it is my personal opinion. I think that EMA and other advanced regulatory authorities could come up with learning tools on the lines of CDER learn etc to understand drug regulatory processes in their respective regions.</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><b><i>Note: </i></b></div><div style="text-align: justify;"><b><i><br />
</i></b></div><div style="text-align: justify;">1.Click on the name of the tools or resources highlighted in red to directly go to the web page of FDA/its affiliate website. For example-CDER Learn (or) you could alternatively click on the references which I have Provided below.</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">2. There could be other useful resources provided by the FDA.<br />
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<b><i>Keywords :</i></b> CDER Learn, FDA Drug Compliance, Information for Industry (Drugs), FDA Voice. </div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><b><i>References-</i></b></div><div style="text-align: justify;"><b><i><br />
</i></b></div><div style="text-align: justify;"><a href="http://www.fda.gov/Training/ForHealthProfessionals/default.htm">http://www.fda.gov/Training/ForHealthProfessionals/default.htm</a> </div><div style="text-align: justify;"><a href="http://fdadrugcompliance.com/">http://fdadrugcompliance.com/</a> </div><div style="text-align: justify;"><a href="http://www.fda.gov/Drugs/ResourcesForYou/Industry/default.htm">http://www.fda.gov/Drugs/ResourcesForYou/Industry/default.htm</a> </div><div style="text-align: justify;"><a href="https://blogs.fda.gov/fdavoice/">https://blogs.fda.gov/fdavoice/</a></div></div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com8tag:blogger.com,1999:blog-7538891640847716324.post-31731202790217422132012-01-06T13:59:00.008+05:302012-01-22T19:58:13.449+05:30ORPHAN DRUGS<div dir="ltr" style="text-align: left;" trbidi="on"><div class="separator" style="clear: both; text-align: center;"></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiMuWc7y3mF2GVuwMk7FSmdEtfpgO4pAjByPoNpveTwsp4G44_VSu_eb9PyCP6ftY0vZgfD1EgG9OBVqiSjx4FXEbDUJFLnwfZXuqCz9CUdDQDY5t0UPvOAX1S_-TsjIHYTfQHhQz9srT0M/s1600/LOGO.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="256" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiMuWc7y3mF2GVuwMk7FSmdEtfpgO4pAjByPoNpveTwsp4G44_VSu_eb9PyCP6ftY0vZgfD1EgG9OBVqiSjx4FXEbDUJFLnwfZXuqCz9CUdDQDY5t0UPvOAX1S_-TsjIHYTfQHhQz9srT0M/s400/LOGO.bmp" width="400" /></a></div><div class="MsoNormal" style="text-align: justify;"><br />
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</span></span></i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="line-height: 115%;"><span style="font-size: small;">I. What are Orphan Drugs?<o:p></o:p></span></span></i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-size: 12pt; line-height: 115%;"><br />
</span></i></b></div><div class="MsoNormal" style="text-align: justify;">In the USA, Orphan Drugs are defined as “those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but it is not expected to recover the costs of developing and marketing a treatment drug”.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal" style="text-align: justify;">In the EU, Orphan Drugs are defined as “those that are intended for diagnosis, prevention or treatment of diseases that affect fewer than 5 in 10,000 people across the EU.”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><b><i>In simple words</i></b> “Orphan Drugs are those, which are intended for the treatment of rare diseases.”</div><div class="MsoNormal"><br />
</div><div class="MsoNormal" style="text-align: justify;">The Companies which are involved in the research and development of Orphan Drugs are provided incentives by the Governments of various countries which are discussed below.</div><div class="MsoNormal" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><b><i>II. What is the need for designation of drugs used in the treatment of rare diseases as orphan drugs and providing incentives to pharmaceutical companies which are involved in developing orphan drugs?<o:p></o:p></i></b></div><div class="MsoNormal"><b><i><br />
</i></b></div><div class="MsoNormal" style="text-align: justify;">For the development and commercialization of new medicines, lot of money and time is involved and moreover, the success rate of new medicines is less. Hence, we cannot expect a pharmaceutical company to work on medicines used for the treatment of rare diseases, since the market for rare diseases is very less. Hence there is a need for providing incentives in order to encourage pharmaceutical companies which are involved in developing orphan drugs.</div><div class="MsoNormal"><br />
</div><div class="MsoNormal" style="text-align: justify;"><b><i>The following may be the general incentives provided by governments of various countries:<o:p></o:p></i></b></div><div class="MsoNormal"></div><ul><li style="text-align: justify;">Tax incentives.</li>
</ul><ul><li style="text-align: justify;">Enhanced patent protection and marketing rights.</li>
</ul><ul><li style="text-align: justify;">Clinical research financial subsidization.</li>
</ul><ul><li style="text-align: justify;">Creating a government-run enterprise to engage in research and development</li>
</ul><div><br />
</div><div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="line-height: 115%;">III. Significant Legislations related to Orphan Drugs in USA and EU-</span></i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="line-height: 115%;"><br />
</span></i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i>a) Orphan Drug Act of 1983-<o:p></o:p></i></b></div><div class="MsoNormal"></div><ul><li style="text-align: justify;">It is a law passed in the United States designed to facilitate the development and commercialization of drugs to treat rare diseases, called Orphan Drugs.</li>
</ul><ul><li style="text-align: justify;"> Orphan drug designation does not indicate that the therapeutic is either safe and effective or legal to manufacture and market in the United States.</li>
</ul><div><div class="MsoNormal"><b><i>Important features of Orphan Drug Act-</i></b></div><div class="MsoNormal"></div><ul><li>The companies developing Orphan Drugs have marketing exclusivity for 7 years.</li>
</ul><ul><li>The companies may get clinical trial tax incentives.</li>
</ul><ul><li>The companies may have reduced taxes from the federal government.</li>
</ul><div><div class="MsoNormal"><b><i>b) Rare Diseases Act- <o:p></o:p></i></b></div><div class="MsoNormal"><div style="text-align: justify;">This legislation amended the Public Health Service Act to establish the Office of Rare Diseases in USA. It also increased funding for the development of treatments for patients with rare diseases.</div></div><div class="MsoNormal"><br />
</div><div class="MsoNormal"></div><div class="MsoNormal" style="text-align: justify;"><b><i>c) REGULATION (EC) No 141/2000 of European Union-<o:p></o:p></i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i><br />
</i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i>Features of REGULATION (EC) No 141/2000-<o:p></o:p></i></b></div><div class="MsoNormal"></div><ul><li style="text-align: justify;">This legislation lays down a Community procedure for the designation of medicinal products as orphan medicinal products. </li>
</ul><ul><li style="text-align: justify;"> It provides incentives for the research, development and placing on the market of designated orphan medicinal products. </li>
</ul><ul><li style="text-align: justify;"> It sets up a Committee for Orphan Medicinal Products (COMP) within the Agency</li>
</ul><ul><li style="text-align: justify;">Orphan drug status granted by the European Commission gives marketing exclusivity in the EU for 10 years after approval</li>
</ul><div><div style="text-align: justify;">In addition to the United States and the European Union, legislation has been implemented by Japan, Singapore, and Australia which have all passed legislation that offers subsidies and other incentives to encourage the development of drugs that treat orphan diseases.</div></div><div style="text-align: justify;"><br />
</div></div><div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="line-height: 18px;">IV.</span></i></b><b><i><span style="line-height: 115%;">Some of the Organizations/offices of Regulatory Agencies associated with Orphan Drugs:</span></i></b></div><div class="MsoNormal" style="text-align: justify;"><b style="text-indent: -0.25in;"><i><br />
</i></b></div><div class="MsoNormal" style="text-align: justify;"><b style="text-indent: -0.25in;"><i>a)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></i></b><b style="text-indent: -0.25in;"><i>FDA Office of Orphan Product Development (<a href="http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/default.htm"><span style="color: red;">OOPD</span></a>)-</i></b></div><div class="MsoNormal" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;">The OOPD has following roles-</div><div class="MsoNormal"></div><ul><li style="text-align: justify;">Evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare disease and to further advance scientific development of such promising medical products.</li>
</ul><ul><li style="text-align: justify;">It provides incentives for sponsors to develop products for rare diseases.</li>
</ul><br />
<div class="MsoListParagraph" style="margin-left: 22.5pt; text-align: justify; text-indent: -0.25in;"><b><i>b)<span style="font: normal normal normal 7pt/normal 'Times New Roman';"> </span></i></b><b><i> National Organization for Rare Disorders (<a href="http://www.rarediseases.org/"><span style="color: red;">NORD</span></a>)-<o:p></o:p></i></b></div><div class="MsoNormal"></div><ul><li style="text-align: justify;">It is a NGO based in USA, involved in providing information, advocacy, research, and patient services to help all patients and families affected by rare diseases.</li>
</ul><ul><li style="text-align: justify;">It was involved in lobbying along with other organizations for passing Orphan Drug Act in USA.</li>
</ul><br />
<div class="MsoNormal" style="text-align: justify;"><b><i>C ) Committee for Orphan Medicinal Products (<a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000263.jsp&mid=WC0b01ac0580028e30&jsenabled=true"><span style="color: red;">COMP</span></a>)-</i></b></div><div class="MsoNormal"></div><ul><li style="text-align: justify;">It is one of the scientific committee of EMA that is responsible for reviewing applications from people or companies seeking orphan medicinal product designation.</li>
</ul><ul><li style="text-align: justify;">It is also responsible for advising the European Commission on the establishment and development of a policy on orphan medicinal products in the EU, and assists the Commission in drawing up detailed guidelines and liaising internationally on matters relating to orphan medicinal products</li>
</ul><br />
<div class="MsoNormal" style="text-align: justify;"><b><i>d) European Organization for Rare Diseases (<a href="http://www.eurordis.org/"><span style="color: red;">EURORDIS</span><span style="color: black;">)</span></a>-<o:p></o:p></i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i><br />
</i></b></div><div class="MsoNormal" style="text-align: justify;">It is an NGO based in Europe, dedicated towards improving quality of life of all people living with rare diseases in Europe.</div><div class="MsoNormal" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="line-height: 18px;">V.</span></i></b><b><i>Significant results due to passage of legislations in support of Orphan Drugs-<o:p></o:p></i></b></div><div class="MsoNormal"></div><ul><li style="text-align: justify;">Many orphan drugs have been developed to treat rare diseases like Hodkins Lymphoma, congenital Factor XIII deficiency. glioma, multiple myeloma, cystic fibrosis, phenylketonuria, snake venom poisoning, neoplastic meningitis etc.</li>
</ul><ul><li style="text-align: justify;">Before enactment of ODA in USA, only 38 drugs were approved to treat orphan diseases. From the passage of the ODA in 1983 until May 2010, the FDA approved 353 orphan drugs and granted orphan designations to 2,116 compounds, which is a significant achievement.</li>
</ul><ul><li style="text-align: justify;">Although the European Medicines Agency grants market access to its 27 member states, medicines only reach the market when each member state decides that its national health system will reimburse for the drug. For example, 35 orphan drugs reached the market in Belgium, 44 in the Netherlands, and 28 in Sweden in 2008. 35 such drugs reached the market in France and 23 in Italy in 2007.</li>
</ul><div style="text-align: justify;"><div class="MsoNormal"><b>Orphan Drugs Approved by the FDA in the year, 2011 (until November, 2011)-</b></div><div class="MsoNormal"><br />
</div><table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-padding-alt: 0in 5.4pt 0in 5.4pt; mso-yfti-tbllook: 1184;"><tbody>
<tr> <td style="border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;"><b>S.No.</b></div></td> <td style="border-left: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;"><b>Name of Drug</b></div></td> <td style="border-left: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;"><b>Indication</b></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">1</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Adcetris(brentuximab vedotin)</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">For treatment of Hodgkin’s lymphoma and ALCL (systemic anaplastic large celllymphoma).</div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">2</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Anascorp(Centruroides [Scorpion] Immune F(ab’)2 [Equine])</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">For treatment of clinical signs of scorpion envenomation.</div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">3</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Caprelsa (vandetanib)</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">To treat adult patients with metastatic (late-stage ) medullary thyroid cancer who are ineligible for surgery and who have disease </div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">that is growing or causing symptoms.</div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">4</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Corifact(Factor XIII Concentrate </div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">[Human])</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">For routine prophylactic treatment of congenital Factor XIII deficiency.</div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">5</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Firazyr(icatibant)</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">For treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages </div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">18 years and older.</div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">6</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Xalkori (crizotinib) and companion genetic test</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">To treat certain patients with late stage (locally advanced or metastatic), non-small cell lung </div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.</div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">7</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Yervoy (ipilimumab)</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">To treat patients with metastatic melanoma (late-stage skin cancer).</div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">8</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Zelboraf (vemuranfenib) </div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">with companion diagnostic</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">To treat patients with metastatic (late-stage) or unresected (cannot be removed by surgery) melanoma (skin cancer) in patients whose tumors express a gene mutation called BRAF V600E.</div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">9</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Nulojix (belatacept)</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">To prevent organ rejection in adult patients who have had a kidney transplant, in combination with </div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">other immunosuppressants.</div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 34.35pt;" valign="top" width="46"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">10</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 175.5pt;" valign="top" width="234"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Spherusol(Coccidioides immitis </div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">Spherule-Derived Skin Test Antigen)</div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 241.05pt;" valign="top" width="321"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">For detection of delayed type hypersensitivity to C. immitis in individuals, 18-64 years of age, </div><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: justify;">with a history of pulmonary coccidioidomycosis</div></td> </tr>
</tbody></table><div class="MsoNormal"><br />
<b style="font-style: italic;"><br />
</b><br />
<b style="font-style: italic;">Keywords- </b>Orphan Drugs, rare diseases, Orphan Drug Act of 1983, <span style="text-align: left;">Rare Diseases Act, </span>Regulation (EC) No 141/2000, OOPD, NORD, COMP, EURORDIS.<br />
.</div></div><div><div class="MsoNormal"><b><i>References-</i></b><br />
1.<a href="http://en.wikipedia.org/wiki/Orphan_drug">http://en.wikipedia.org/wiki/Orphan_drug</a> <br />
2.<a href="http://en.wikipedia.org/wiki/Orphan_Drug_Act">http://en.wikipedia.org/wiki/Orphan_Drug_Act</a> </div><div class="MsoNormal"></div><div class="MsoNormal">3.<a href="http://en.wikipedia.org/wiki/National_Organization_for_Rare_Disorders">http://en.wikipedia.org/wiki/National_Organization_for_Rare_Disorders</a></div><div class="MsoNormal"></div><div class="MsoNormal"><a href="http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004736.pdf">http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004736.pdf</a></div><div class="MsoNormal">4.<a href="http://www.rarediseases.org/about/vision-mission">http://www.rarediseases.org/about/vision-mission</a></div><div class="MsoNormal"></div><div class="MsoNormal">5.<a href="http://www.eurordis.org/content/brief-0">http://www.eurordis.org/content/brief-0</a></div>6.<a href="http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM278358.pdf">http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM278358.pdf</a><br />
7.<a href="http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000263.jsp&mid=WC0b01ac0580028e30&jsenabled=true">http://www.ema.europa.eu/ema/index.jspcurl=pages/about_us/general/general_content_000263.jsp&mid=WC0b01ac0580028e30&jsenabled=true</a><br />
8.<a href="http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/default.htm">http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/default.htm</a> <br />
9.<a href="http://www.fda.gov/downloads/Drugs/NewsEvents/UCM182553.pdf">http://www.fda.gov/downloads/Drugs/NewsEvents/UCM182553.pdf</a></div></div></div></div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com6tag:blogger.com,1999:blog-7538891640847716324.post-71245843751042904882011-12-30T22:57:00.007+05:302012-03-19T13:04:56.714+05:30HATCH-WAXMAN ACT<div dir="ltr" style="text-align: left;" trbidi="on"><br />
<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEitJlNqU-qqiJPrRib02Tj-BI75fyssWAxjRIghsGXwDmH2xBhm-Zk8AE33z7FtbfZHt9fQy9vAwvMErZdu5AqnIPd7D6K-eyUQUmwJxjO7dOxIB95HWuh5MUicimi0vNrVQP1VMtmhrtBx/s1600/LOGO.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="236" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEitJlNqU-qqiJPrRib02Tj-BI75fyssWAxjRIghsGXwDmH2xBhm-Zk8AE33z7FtbfZHt9fQy9vAwvMErZdu5AqnIPd7D6K-eyUQUmwJxjO7dOxIB95HWuh5MUicimi0vNrVQP1VMtmhrtBx/s400/LOGO.bmp" width="400" /></a></div><div class="separator" style="clear: both; text-align: justify;"> </div><div class="MsoNormal" style="text-align: justify;"><br />
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</div><div class="MsoNormal" style="text-align: justify;"><b>What is Hatch-Waxman act?<o:p></o:p></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">It is the popular name for Drug Price Competition and Patent Term Restoration Act, 1984. It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file Abbreviated New Drug Application (ANDA) to seek FDA approval of generic drugs.<span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial; font-family: Arial, sans-serif; font-size: 10pt; line-height: 115%;"> </span>Paragraph IV of the act, allows 180 day exclusivity to companies that are the "first-to-file" an ANDA against holders of patents for branded counterparts.</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i>In simple words</i></b> “Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics through Abbreviated New Drug Applications (ANDAs)”</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><br />
</b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><i><b>Significant results due to Hatch-Waxman act-</b></i><b><o:p></o:p></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"></div><ul><li style="text-align: justify;">Prior to the Hatch and Waxman act the generic drug manufacturer had to do the entire clinical trials. After the passage of Hatch and Waxman act the generic drug manufacturer had to only prove bioequivalence of generic drug to the innovator drug by showing that the generic drug is 80-125% bioequivalent to the innovator drug.</li>
</ul><ul><li style="text-align: justify;">The time and cost involved for getting the generic drug into the market was significantly reduced.</li>
</ul><ul><li style="text-align: justify;">Low cost quality, safe and effective generic drugs were available to the patients.</li>
</ul><ul><li style="text-align: justify;">Since 1984, over 10,000 generic drugs have entered the market, and generics accounted for close to 50 percent of prescriptions filled (as on august 1, 2003).</li>
</ul><ul><li style="text-align: justify;">Billions of dollars in health care costs are being saved annually.</li>
</ul><br />
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i>Patents and Exclusivity</i><o:p></o:p></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><br />
</b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">Generic drug approval process isn’t less complicated as it involves patent and exclusivity issues. If any New Molecular Entity (NME) is approved, it is granted a exclusivity period of 5 years, which could be extended to 3 more years for supplements requiring clinical trials.</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b>Patent Certifications<o:p></o:p></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><br />
</b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the “Orange Book” for the innovator drug. This certification must state one of the following:</div><div class="MsoNormal" style="text-align: justify;"></div><ul><li style="text-align: justify;">(I) that the required patent information relating to such patent has not been filed (Para I certification);</li>
</ul><ul><li style="text-align: justify;">(II) that such patent has expired (Para II certification);</li>
</ul><ul><li style="text-align: justify;">(III) that the patent will expire on a particular date (Para III certification); or</li>
</ul><ul><li style="text-align: justify;">(IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought(Para IV certification).</li>
</ul><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">A paragraph IV certification, however, begins a process in which the question of whether the listed patent is valid or will be infringed by the proposed generic product may be answered by the courts before the expiration of the patent. Under the current regulations, the ANDA applicant who files a paragraph IV certification to a listed patent must notify the patent owner and the NDA holder for the listed drug that it has filed an ANDA containing a patent challenge. Until the effective date of FDA’s final rule, all patents submitted and listed in the Orange Book that are the subject of a paragraph IV certification require notice to the NDA holder and patent owner. The notice must include a detailed statement of the factual and legal basis for the ANDA applicant’s opinion that the patent is not valid or will not be infringed.</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">The submission of an ANDA for a drug product claimed in a patent is an infringing act if the generic product is intended to be marketed before expiration of the patent. Accordingly, the ANDA applicant who submits an application containing a paragraph IV certification may be sued for patent infringement. If the NDA holder or patent owner files a patent infringement suit against the ANDA applicant within <b>45 days of the receipt of notice</b>, FDA may not give final approval to the ANDA for at least 30 months from the date of that notice. This <b>30-month</b> stay will delay approval of the generic drug product unless the court reaches a decision earlier in the patent infringement case or otherwise orders a longer or shorter period for the stay. </div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><b><i>180 Day Exclusivity</i><o:p></o:p></b></div><div class="MsoNormal" style="text-align: justify;"><b><br />
</b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit.</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">The statute provides that the first applicant to file a substantially complete ANDA containing a paragraph IV certification to a listed patent will be eligible for a 180-day period of exclusivity beginning either from the date it begins commercial marketing of the generic drug product, or from the date of a court decision finding the patent invalid, unenforceable or not infringed, whichever is first.</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;">180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor ( Atorvastatin calcium).</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><o:p></o:p></div><div class="MsoNormal" style="text-align: justify;"><i style="font-weight: bold;">Keywords: </i>Drug price competition and patent term restoration act-1984, ANDA, generics,180 day exclusivity, 80-125% bioequivalence, 505 (b) (2) application, Para I certification, Para II certification, Para III certification, Para IV certification.</div><div class="MsoNormal" style="text-align: justify;"><b><i><br />
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<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><i>References-</i></b></div><div class="MsoListParagraphCxSpFirst" style="mso-list: l0 level1 lfo1; text-align: justify; text-indent: -.25in; text-justify: inter-ideograph;">1.<span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span><a href="http://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act">http://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act</a></div><div class="MsoListParagraphCxSpLast" style="mso-list: l0 level1 lfo1; text-align: justify; text-indent: -.25in; text-justify: inter-ideograph;">2.<span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span><a href="http://www.fda.gov/newsevents/testimony/ucm115033.htm">http://www.fda.gov/newsevents/testimony/ucm115033.htm</a></div><div class="MsoListParagraphCxSpLast" style="mso-list: l0 level1 lfo1; text-align: justify; text-indent: -.25in; text-justify: inter-ideograph;"><br />
</div><div class="MsoListParagraphCxSpLast" style="mso-list: l0 level1 lfo1; text-align: justify; text-indent: -.25in; text-justify: inter-ideograph;"></div><div class="MsoNormal" style="text-align: justify; text-indent: 0px;"><i><b>P.S.-</b></i></div><div class="MsoNormal" style="text-align: justify; text-indent: 0px;">A generic drug product is the one, that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.</div><br />
</div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com59tag:blogger.com,1999:blog-7538891640847716324.post-31568973643164142242011-12-23T13:45:00.002+05:302012-03-19T13:07:29.756+05:30505 (b)(2) application<div dir="ltr" style="text-align: left;" trbidi="on"><div style="text-align: justify;"><br />
</div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhT9uGBBNek_oUofF0I2jzptFUItQvKCqDENMHbVarEtVYpgaOI8r-wOgyC_A9yRF5wr833QJ2ycqj-fl95vFmJjlNTzH4aJdKWyrmgM1XoDS87dQRtGRDe94IEDThN7YxbIGqbuDPB5uyl/s1600/505+b%25282%2529.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="235" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhT9uGBBNek_oUofF0I2jzptFUItQvKCqDENMHbVarEtVYpgaOI8r-wOgyC_A9yRF5wr833QJ2ycqj-fl95vFmJjlNTzH4aJdKWyrmgM1XoDS87dQRtGRDe94IEDThN7YxbIGqbuDPB5uyl/s400/505+b%25282%2529.bmp" width="400" /></a></div><div style="text-align: justify;"><br />
</div><div class="MsoNormal"><div style="text-align: justify;"><b><i><span style="font-family: inherit;">What is a 505 (b) (2) application?</span></i></b></div></div><div class="MsoNormal"><div style="text-align: justify;"><b><i><span style="font-family: inherit;"><br />
</span></i></b></div></div><div class="MsoNormal"><div style="text-align: justify;"><span style="font-family: inherit;">An application submitted under section 505(b)(1) of the Federal Food, Drug and Cosmetics act for a drug for which one or more of the investigations relied on by the applicant for approval of the "application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted"</span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div></div><div class="MsoNormal"></div><div class="MsoNormal"><div style="text-align: justify;"><b><i>In simple words</i></b> “505 (b)(2) application is a type of NDA for which one or more investigation relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference”</div></div><div class="MsoNormal"><div style="text-align: justify;"><br />
</div></div><div class="MsoNormal"></div><div class="MsoNormal"><div style="text-align: justify;">Section 505(b)(2) was added to the Food, Drug and Cosmetics act by the <b>Drug Price Competition and Patent Term Restoration Act of 1984 (popularly known as Hatch-Waxman Amendments)</b>.</div></div><div class="MsoNormal"><div style="text-align: justify;"><br />
</div></div><div class="MsoNormal"><div style="text-align: justify;"><b><i>What type of information can an applicant rely on ?</i></b></div></div><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;">Published literature</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">The agency's finding of safety and effectiveness of an approved drug.</li>
</ul><div><div class="MsoNormal"><div style="text-align: justify;"><b><i>What kind of application can be submitted as a 505(b)(2) application?</i></b></div></div><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;">New chemical entity (NCE)/new molecular entity (NME)</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Changes to previously approved drugs</li>
</ul><div style="text-align: justify;"><br />
</div><div class="MsoNormal"><div style="text-align: justify;"><b><i>Examples of changes to approved drug products for which 505(b)(2) application should be submitted</i></b></div></div><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;">Change in dosage form.</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Change in strength</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Change in route of administration</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Substitution of an active ingredient in a formulation product</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Change in formulation</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Change in dosing regimen</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Change in active ingredient</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"> New combination Product</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">New indication</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Change from prescription indication to OTC indication</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Naturally derived or recombinant active ingredient</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Bioinequivalence</li>
</ul><div><div class="MsoNormal"><div style="text-align: justify;"><br />
</div></div><div class="MsoNormal"><div style="text-align: justify;"><b><i>What can't be submitted as 505(b)(2) applications?</i></b></div></div><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;">An application that is a duplicate of a listed drug and eligible for approval under section 505(j) (ANDA)</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">An application in which the only difference from the reference listed drug is that the extent to which the active ingredient(s) is absorbed or otherwise made available to the site of action is less than the listed drug</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">An application in which the only difference from the reference listed drug is that the rate at which its active ingredient(s) is absorbed or otherwise made available to the site of action is unintentionally less than that of the listed drug</li>
</ul><div><div class="MsoNormal"><div style="text-align: justify;"><b><i>Advantages of 505 (b)(2) application-</i></b></div></div><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;">A 505(b)(2) application may itself be granted 3 or 5 years of exclusivity</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Time-consuming , costly and duplication of clinical studies can be eliminated</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">A 505(b)(2) application may be eligible to qualify for orphan and/or pediatric drug exclusivity</li>
</ul><div><div class="MsoNormal"><div style="text-align: justify;"><b><i>Challenge-</i></b></div></div><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;">505(b)(2) application may be delayed due to patent or exclusivity protections covering an approved product</li>
</ul></div></div></div></div><div style="text-align: justify;">I found a useful link which is provided below, wherein you could get useful information on differences between 2 types of NDA and ANDA, examples of medication approved under 505 (b)(2) application , Q & A related to 505 (b)(2) application, learning assessment etc</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><a href="http://www.cedrugstorenews.com/userapp/appdown.html?CFID=2677216&CFTOKEN=82970149">Understanding 505 (b)(2) by Lauren S. Schlesselman</a><br />
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<b><i>Key Words</i></b>- 505 (b)(2) application, Hatch-Waxman amendments.</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><b><i>Reference-</i></b></div><div style="text-align: justify;"><a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079345.pdf">http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079345.pdf</a> <br />
<a href="http://www.cedrugstorenews.com/userapp/appdown.html?CFID=2677216&CFTOKEN=82970149">http://www.cedrugstorenews.com/userapp/appdown.html?CFID=2677216&CFTOKEN=82970149</a> </div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><i><b>Other useful Links-</b></i></div><div style="text-align: justify;"></div><div class="MsoNormal"><a href="http://www.camargopharma.com/Userfiles/Docs/camargo-505b2.pdf">The 505(b)(2) Alternative— An NDA that Saves Time and Money</a></div><div class="MsoNormal"><a href="http://www.regprofessional.com/resources/505(b)(2).pdf">The 505(b)(2) New Drug Application – A Rapid Approval Route</a></div><div class="MsoNormal"></div><div class="MsoNormal"><a href="http://www.amarexcro.com/articles/docs/RAPS_Focus_505b2_Apr2010.pdf">The 505(b)(2): Drug Development Pathway</a></div><br />
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</div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com7tag:blogger.com,1999:blog-7538891640847716324.post-42019760925345609702011-12-17T18:01:00.015+05:302015-06-28T13:34:41.166+05:30New Drug Application (NDA)<div dir="ltr" style="text-align: left;" trbidi="on">
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiNj5zWfh3NEnd2t0kj0NJLju6CIBQgbJY0uGWwJfM_ftMrKm71PLMbkUE3Trkjonx17-XkiZveJAXuYjWA_Cpynj1RrR3HGUT7EehYl530yDSSWtHHnuMTA_Y-Zqf2lMKrx8pU0QQ9IcGf/s1600/logo.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="220" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiNj5zWfh3NEnd2t0kj0NJLju6CIBQgbJY0uGWwJfM_ftMrKm71PLMbkUE3Trkjonx17-XkiZveJAXuYjWA_Cpynj1RrR3HGUT7EehYl530yDSSWtHHnuMTA_Y-Zqf2lMKrx8pU0QQ9IcGf/s400/logo.bmp" width="400" /></a></div>
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<b><i>What is a New Drug Application (NDA)?</i></b></div>
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The NDA is the vehicle through which drug sponsors (pharma companies) formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.</div>
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<div class="MsoNormal" style="text-align: justify;">
In simple terms “It is an application filed with USFDA to get approval for marketing a new pharmaceutical for sale in the U.S.”</div>
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Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization.</div>
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<b><i>I. Goals of NDA-</i></b></div>
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The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:</div>
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<ul style="text-align: left;">
<li style="text-align: justify;">Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.</li>
</ul>
<ul style="text-align: left;">
<li style="text-align: justify;">Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.</li>
</ul>
<ul style="text-align: left;">
<li style="text-align: justify;">Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.</li>
</ul>
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<b><i>II. Chemical type and review classification codes for NDA-</i></b></div>
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<b><i>Chemical type classification</i></b><br />
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<b><i><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">Meaning</span></i></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 49.5pt;" valign="top" width="66"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">1<o:p></o:p></span></div>
</td>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 274.5pt;" valign="top" width="366"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;"> New molecular entity (NME)<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 49.5pt;" valign="top" width="66"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">2<o:p></o:p></span></div>
</td>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 274.5pt;" width="366"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;"> New active ingredient
(new salt, new noncovalent <o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;"> derivative, new </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">ester</span><span style="color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;">)<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 49.5pt;" valign="top" width="66"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">3<o:p></o:p></span></div>
</td>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 274.5pt;" valign="top" width="366"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="background: white; color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;"> New
dosage form</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;"><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 49.5pt;" valign="top" width="66"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">4<o:p></o:p></span></div>
</td>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 274.5pt;" valign="top" width="366"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;"> New combination<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 49.5pt;" valign="top" width="66"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">5<o:p></o:p></span></div>
</td>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 274.5pt;" width="366"><div class="MsoNormal" style="line-height: 14.45pt; margin-bottom: .0001pt; margin-bottom: 0cm;">
<span style="color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;"> New formulation or new
manufacturer<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 49.5pt;" valign="top" width="66"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">6<o:p></o:p></span></div>
</td>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 274.5pt;" valign="top" width="366"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;"> New indication [no longer used]<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 49.5pt;" valign="top" width="66"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">7<o:p></o:p></span></div>
</td>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 274.5pt;" valign="top" width="366"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;"> Drug already marketed without an approved
NDA<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 49.5pt;" valign="top" width="66"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">8<o:p></o:p></span></div>
</td>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 274.5pt;" valign="top" width="366"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;"> OTC (over-the-counter) switch<o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 49.5pt;" valign="top" width="66"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">9<o:p></o:p></span></div>
</td>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 274.5pt;" width="366"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;"> New indication
submitted as distinct NDA, <o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;"> consolidated with
original NDA after </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">approval</span><span style="color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;"><o:p></o:p></span></div>
</td>
</tr>
<tr>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 49.5pt;" valign="top" width="66"><div align="center" class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">10<o:p></o:p></span></div>
</td>
<td style="border: inset 1.0pt; mso-border-alt: inset windowtext .5pt; padding: 0cm 0cm 0cm 0cm; width: 274.5pt;" width="366"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;"> New </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-IN;">indication</span><span style="color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;">
submitted as distinct NDA - not <o:p></o:p></span></div>
<div class="MsoNormal" style="margin-bottom: 0.0001pt;">
<span style="color: #333333; font-family: "Times New Roman","serif"; font-size: 12.0pt;"> consolidated<o:p></o:p></span></div>
</td>
</tr>
</tbody></table>
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>Review Classification</i></b></div>
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-bottom-style: none; border-collapse: collapse; border-color: initial; border-image: initial; border-left-style: none; border-right-style: none; border-top-style: none; border-width: initial; text-align: justify;"><tbody>
<tr> <td style="border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 54.9pt;" valign="top" width="73"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<b><i>Letter<o:p></o:p></i></b></div>
</td> <td style="border-left: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 373.5pt;" valign="top" width="498"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<b><i>Meaning<o:p></o:p></i></b></div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 54.9pt;" valign="top" width="73"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
P</div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 373.5pt;" valign="top" width="498"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Priority review drug: A drug that appears to represent an advance over available therapy</div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 54.9pt;" valign="top" width="73"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
S</div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 373.5pt;" valign="top" width="498"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug</div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 54.9pt;" valign="top" width="73"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
O</div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 373.5pt;" valign="top" width="498"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Orphan drug - a product that treats a rare disease affecting fewer than 200,000 Americans</div>
</td> </tr>
</tbody></table>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<br />
<div class="MsoNormal" style="text-align: justify;">
<b><i><br />
</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>III. Facility and Drug Registration for filing an NDA-</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i> </i></b>Within 5 days of filing the NDA-</div>
<div class="MsoNormal">
</div>
<ul style="text-align: left;">
<li><span style="text-align: justify;"> </span><span style="text-align: justify;">The facility should be registered with FDA using form FDA 2656(Registration of Drug Establishment/Labeler Code Assignment form).</span></li>
</ul>
<ul style="text-align: left;">
<li style="text-align: justify;">The product(s)/Drugs to be listed with FDA using form FDA 2657 (Drug listing form) .</li>
</ul>
<div style="text-align: justify;">
Note : From June 1, 2009 FDA is accepting only electronic submissions of forms FDA 2656 and 2657.</div>
<div style="text-align: justify;">
<br /></div>
<br />
<div class="MsoNormal" style="text-align: justify;">
<b><i>IV. Format and content of NDA-</i></b><br />
<b><i><br />
</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
The FDA recommends ICH’s CTD for filing the NDA.<br />
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
Documents in each Module-</div>
<br />
<div class="MsoNormal">
</div>
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-bottom-style: none; border-collapse: collapse; border-color: initial; border-image: initial; border-left-style: none; border-right-style: none; border-top-style: none; border-width: initial; text-align: justify;"><tbody>
<tr> <td style="border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 59.4pt;" valign="top" width="79"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<b><i>Module<o:p></o:p></i></b></div>
</td> <td style="border-left: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 419.4pt;" valign="top" width="559"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
<b><i>Information<o:p></o:p></i></b></div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 59.4pt;" valign="top" width="79"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
1<o:p></o:p></div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 419.4pt;" valign="top" width="559"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Administrative and prescribing information (region specific)<o:p></o:p></div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 59.4pt;" valign="top" width="79"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
2<o:p></o:p></div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 419.4pt;" valign="top" width="559"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Summaries and overview<o:p></o:p></div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 59.4pt;" valign="top" width="79"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
3<o:p></o:p></div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 419.4pt;" valign="top" width="559"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Information on product quality<o:p></o:p></div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 59.4pt;" valign="top" width="79"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
4<o:p></o:p></div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 419.4pt;" valign="top" width="559"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Nonclinical study reports<o:p></o:p></div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 59.4pt;" valign="top" width="79"><div class="MsoNormal" style="margin-bottom: 0.0001pt; text-align: center;">
5<o:p></o:p></div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 419.4pt;" valign="top" width="559"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Clinical study reports<o:p></o:p></div>
</td> </tr>
</tbody></table>
<br />
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<b><i>Module 1- Administrative and prescribing information</i></b></div>
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Documents should be organized in the order listed below. Generally, all of the documents in Module 1 can be provided in a single volume. Environmental assessments should be submitted separately.</div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>1. FDA form 356h</i></b> </div>
<div class="MsoNormal">
</div>
<ul style="text-align: left;">
<li style="text-align: justify;">The first document in Module 1 should be <span style="color: red;"><a href="http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/ucm082348.pdf"><span style="color: red;">FDA form 356h</span></a>.</span></li>
</ul>
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<b><i>2. Comprehensive table of contents</i></b></div>
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The next document in Module 1 should be the comprehensive table of contents for the entire submission. Each NDA submission is required to have a comprehensive table of contents or index for the entire submission (as per <a href="http://edocket.access.gpo.gov/cfr_2010/aprqtr/21cfr314.50.htm"><span style="color: red;">21 CFR 314.50</span></a>)</div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>3. Administrative documents</i></b></div>
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<b><i>a. Administrative documents</i></b></div>
<div class="MsoNormal">
</div>
<ul style="text-align: left;">
<li style="text-align: justify;">Appropriate administrative documents should be provided with the submission. Examples of administrative documents are listed below. <a href="http://edocket.access.gpo.gov/cfr_2010/aprqtr/21cfr314.50.htm"><span style="color: red;">21 CFR 314.50</span></a> consists of details on the administrative documents needed for NDA.</li>
</ul>
<br />
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· Patent information on any patent that claims the drug, if applicable</div>
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· Patent certifications </div>
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· Debarment certification</div>
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· Field copy certification </div>
<div class="MsoNormal" style="text-align: justify;">
· User fee cover sheet </div>
<div class="MsoNormal" style="text-align: justify;">
· Financial disclosure information</div>
<div class="MsoNormal" style="text-align: justify;">
· Letters of authorization for reference to other applications or drug master files (if applicable)</div>
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· Waiver requests</div>
<div class="MsoNormal" style="text-align: justify;">
· Environmental assessment or request for categorical exclusion</div>
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· Statements of claimed exclusivity and associated certifications<br />
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="line-height: 115%;"><span style="font-family: inherit;">*Environmental assessment should be provided as a separate volume.</span></span><br />
<br /></div>
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<b><i>b.Prescribing information</i></b></div>
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All copies of the labels and all labeling for the product should be included. Examples are provided below-</div>
<div class="MsoNormal" style="text-align: justify;">
<ul>
<li>Container and package labels</li>
<li>Package inserts</li>
<li>Draft labeling</li>
<li>Patient leaflets</li>
<li>Information sheets</li>
<li>Medication Guides</li>
</ul>
</div>
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<b><i>c. Annotated labeling text </i></b> </div>
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A copy of the proposed labeling text with annotations directing reviewers to the information in the summaries and other modules that support each statement in the labeling should be provided.</div>
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<br /></div>
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<b><i> Module 2 – Common Technical Document Summaries</i></b></div>
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Module 2 should include the summary documents. The documents for this module should be provided in the order as described below.</div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>1. Overall CTD table of contents</i></b></div>
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For the first document in this module, a comprehensive table of Contents should be provided listing all of the documents provided in the submission for modules 2 through 5.</div>
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<br /></div>
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<b><i>2. Introduction to the summary documents</i></b></div>
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Introduction to the summary should be provided as described in the guidance document <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf"><span style="color: red;">M4: Organization of the CTD</span></a> as a one page document.</div>
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<br /></div>
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<b><i>3. Overviews and summaries</i></b></div>
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Module 2 should contain the following additional documents as described in the appropriate guidance documents (<a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf"><span style="color: red;">M4Q: The CTD -Quality</span></a>,<span style="color: red;"> <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R2__Safety/M4S_R2_.pdf"><span style="color: red;">M4S:The CTD - Safety</span></a>,</span> <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R1__Efficacy/M4E__R1_.pdf"><span style="color: red;">M4E: The CTD – Efficacy</span></a>):</div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
·Quality overall summary (2.3, Module 2, section 3)</div>
<div class="MsoNormal" style="text-align: justify;">
· Non clinical overview (2.4)</div>
<div class="MsoNormal" style="text-align: justify;">
· Clinical overview (2.5)</div>
<div class="MsoNormal" style="text-align: justify;">
· Nonclinical summary (2.6)</div>
<div class="MsoNormal" style="text-align: justify;">
· Clinical summary (2.7)</div>
<div class="MsoNormal" style="text-align: justify;">
The nonclinical summary and the clinical summary should be provided in separate volumes for ease of use by reviewers.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="text-align: left;"><b><i> Module 3 - Quality</i></b></span></div>
<div class="MsoNormal" style="text-align: justify;">
Module 3 should include information on the drug and product that should be provided in the order described below. </div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>1. Module 3 table of contents</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
The first document in this module should be a table of contents listing all of the documents provided for module 3. See the guidance document <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf"><span style="color: red;">M4Q: The CTD Quality</span></a> for the headings and order to be used in the table of contents, including numbering of section headings.</div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>2. Body of data</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
Each individual subsection related to the drug and product should be provided as an individual document either bound separately or divided by tab identifiers, depending on the size of the subsection. The documents should be presented in the order in which they are listed in the table of contents.</div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>3. Literature References</i></b></div>
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Each literature reference should be provided as an individual document, separated from the others by tab identifiers.</div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>Module 4 - Nonclinical Study Reports</i></b></div>
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Module 4 should contain the nonclinical study reports and related information. The documents should provide for this module in the order described below-</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>1. Module 4 table of contents</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
The first document in this module should be a table of contents listing all of the documents provided for module 4. See the guidance to industry <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R2__Safety/M4S_R2_.pdf"><span style="color: red;">M4S: The CTD – Safety</span></a> for the headings and order to be used in the table of contents, including numbering of section headings.</div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>2. Study reports and related information</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
<o:p> </o:p>Each study report and each related document should be provided as an individual document, separated from the other documents by binders or tab identifiers. These documents should be presented in the order in which they are listed in the table of contents.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>3. Literature References</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
Each literature reference should be provided as an individual document, separated from the others by tab dividers.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>Module 5 - Clinical Study Reports</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
Module 5 should contain clinical study reports and related information. The documents for this module should be provided in the order described below.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>1. Module 5 table of contents</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
The first document in this module should be a table of contents listing all of the documents provided in Module 5. See the guidance to industry <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4__R1__Efficacy/M4E__R1_.pdf"><span style="color: red;">M4E: The CTD – Efficacy</span></a> for the headings and order to be used in the table of contents, including numbering of section headings.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>2. Study reports and related information</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
Each study report and each related document should be provided , such as tabular listings of all clinical studies, as an individual document separated from the other documents by binders or tab dividers. Tab identifiers be provided for each appendix in a study report. These documents should be presented in the order in which they are listed in the table of contents.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>3. Literature References</i></b></div>
<div class="MsoNormal" style="text-align: justify;">
Each literature reference should be provided as an individual document separated from the others by tab identifiers.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>V. Number of Copies of NDA-</i></b> The regulations requires archival, review, and field copies of NDAs</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>1.Archival Copy-</i></b> The archival copy is a complete copy of the application. It serves as the official archive of the application and may be used during the review of the application.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>2. Review copy-</i></b> It includes the information needed by each review discipline for its evaluation. These copies facilitate the concurrent review of the application by the different review disciplines. Review copies that may be necessary according to 21 CFR 314.50 for an individual submission include:</div>
<div class="MsoNormal" style="text-align: justify;">
· Quality (Module 3),</div>
<div class="MsoNormal" style="text-align: justify;">
· Nonclinical (Module 4),</div>
<div class="MsoNormal" style="text-align: justify;">
· Clinical (Module 5) - safety and efficacy documents for clinical reviewer</div>
<div class="MsoNormal" style="text-align: justify;">
· Clinical (Module 5) - safety and efficacy documents for the statistical reviewer,</div>
<div class="MsoNormal" style="text-align: justify;">
· Clinical (Module 5) - clinical pharmacology and pharmacokinetics documents </div>
<div class="MsoNormal" style="text-align: justify;">
· Clinical (Module 5) – clinical microbiology documents.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
Copy of Modules 1 and 2 should be provided in each review copy. Each review copy should be labeled and bound separately.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>3. Field copy-</i></b>The field copy should be a separately bound copy of the Quality section (Module 3) for the NDA.</div>
<div class="MsoNormal" style="text-align: justify;">
<br />
<b><i>VI. Paper size, font size, pagination, binder colors and mailing address-</i></b><br />
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i> Paper size-</i></b>Standard U.S. letter size paper (8.5 x 11 inches) should be used for all submissions.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>Font size-</i></b>Narrative text be submitted in Times New Roman 12 point font. Font sizes 9 to10 points are considered acceptable in tables.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>Pagination-</i></b>Page numbering should be at the document level and not at the volume or module level. (The entire submission should never be numbered consecutively by page.) In general, all documents should have page numbers. Since the page numbering is at the document level, there should only be one set of page numbers for each document.</div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>Binder Colors for NDA Review Copies</i></b></div>
<table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-bottom-style: none; border-collapse: collapse; border-color: initial; border-image: initial; border-left-style: none; border-right-style: none; border-top-style: none; border-width: initial; text-align: justify;"><tbody>
<tr> <td style="border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Review copy for:</div>
</td> <td style="border-left: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Binder color</div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Quality</div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Red</div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Nonclinical</div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Yellow</div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Clinical- pharmacokinetics and bioavailability</div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Orange</div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Clinical – microbiology</div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
White</div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Clinical - safety and efficacy</div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
clinical Tan</div>
</td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
Clinical - safety and efficacy</div>
</td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 239.4pt;" valign="top" width="319"><div class="MsoNormal" style="margin-bottom: 0.0001pt;">
statistical Green</div>
</td> </tr>
</tbody></table>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<o:p><br />
</o:p></div>
<div class="MsoNormal" style="text-align: justify;">
<b><i>Mailing Address for New Drug Applications (NDAs)</i></b></div>
<div class="MsoNormal">
</div>
<div style="text-align: justify;">
CDER Central Document Room:</div>
<div style="text-align: justify;">
FDA/Center for Drug Evaluation and Research (CDER)</div>
<div style="text-align: justify;">
Central Document Room (CDR)</div>
<div style="text-align: justify;">
5901-B Ammendale Road</div>
<div style="text-align: justify;">
Beltsville, MD 20705-1266</div>
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<o:p><b><i>VII. Review Process of NDA-</i></b></o:p></div>
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<a href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM276984.pdf"><span style="color: red;">NDA approvals by CDER for the year, 2011</span></a></div>
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<o:p><b><i>References-</i></b></o:p></div>
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1.<b style="font-style: italic;"> </b><a href="http://en.wikipedia.org/wiki/New_Drug_Application" style="text-align: left;">http://en.wikipedia.org/wiki/New_Drug_Application</a></div>
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2.<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073276.pdf" style="text-align: left;">http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073276.pdf</a></div>
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3.<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073308.pdf" style="text-align: left;">http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073308.pdf</a></div>
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4.<a href="http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm" style="text-align: left;">http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm</a></div>
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5.<a href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/PriorityNDAandBLAApprovals/UCM081953.pdf" style="text-align: left;">http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/PriorityNDAandBLAApprovals/UCM081953.pdf</a></div>
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6.<a href="http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm#chemtype_reviewclass" style="text-align: left;">http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm#chemtype_reviewclass</a><br />
7.<a href="http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129720.pdf">http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129720.pdf</a><br />
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Guidance documents for NDAs is provided in the following link-<br />
<a href="http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm">http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm</a> <br />
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<b><i>Keywords :</i></b> NDA, NME, form FDA 2656, form FDA 2657, CTD, 21 CFR 314.50, CDER.<br />
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<b><i>P.S-</i></b><br />
1.This article is intended to provide guidance only for filing paper format of NDA.<br />
2. Part of the article is based on Draft Guidance.<br />
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Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com5tag:blogger.com,1999:blog-7538891640847716324.post-9137378779963499022011-12-09T15:15:00.011+05:302012-03-19T13:15:51.934+05:30Drug Approval Procedures in European Union<div dir="ltr" style="text-align: left;" trbidi="on"><div style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="separator" style="clear: both; text-align: justify;"><span style="font-family: inherit;"> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiObM_eDv4l-HNf1CHv0lQ0NwTHygMBPGsG5nQSY-ARUX1g46gVGYjLBKC2sFUzpJuKrFN2t2jjNONELI2IkweThqaxHjAR8OcnVP-wI1KJAQRCbHt0kt9IPwYTbATRzOzLFEMtZcR1pfyg/s1600/Euro_Flag.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="278" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiObM_eDv4l-HNf1CHv0lQ0NwTHygMBPGsG5nQSY-ARUX1g46gVGYjLBKC2sFUzpJuKrFN2t2jjNONELI2IkweThqaxHjAR8OcnVP-wI1KJAQRCbHt0kt9IPwYTbATRzOzLFEMtZcR1pfyg/s400/Euro_Flag.png" width="400" /></a></span></div><div class="MsoNormal"><div style="text-align: justify;"><span style="font-family: inherit;"><o:p> </o:p> </span></div></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;">Before starting off on drug approval procedures in European Union, I would like to present a table on European Union member countries and Non-European union member countries since the drug approval procedures are not necessarily the same throughout the Europe.<o:p></o:p></span></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><table border="1" cellpadding="0" cellspacing="0" class="MsoTableGrid" style="border-bottom-style: none; border-collapse: collapse; border-color: initial; border-left-style: none; border-right-style: none; border-top-style: none; border-width: initial; margin-left: 5.4pt; text-align: justify;"><tbody>
<tr> <td style="border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><b><i>European Union member countries</i></b><o:p></o:p></span></div></td> <td style="border-left: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-themecolor: text1; mso-border-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><b><i>Non-European union member countries</i></b><o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Austria<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Iceland *<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Belgium<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Norway *<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Bulgaria<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Switzerland<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Cyprus<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Serbia<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Czech Republic<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Montenegro<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Denmark<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Croatia<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Estonia<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Bosnia-Herzegovina<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Finland<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Macedonia (Former Republic of Yugoslav)</span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">France<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Albania<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Germany<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Andorra<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Greece<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Belarus<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Hungary<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Moldova<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Ireland<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Monaco *<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Italy<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">San Marino<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Latvia<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Liechtenstein *<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Lithuania<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Vatican City<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Luxembourg<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Russia<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Malta<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Ukraine<o:p></o:p></span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Netherlands<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Georgia</span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Poland<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Portugal<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Romania<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Slovakia<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Slovenia<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Spain<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Sweden<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div></td> </tr>
<tr> <td style="border-top: none; border: solid black 1.0pt; mso-border-alt: solid black .5pt; mso-border-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 220.5pt;" valign="top" width="294"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">United Kingdom<o:p></o:p></span></div></td> <td style="border-bottom: solid black 1.0pt; border-left: none; border-right: solid black 1.0pt; border-top: none; mso-border-alt: solid black .5pt; mso-border-bottom-themecolor: text1; mso-border-left-alt: solid black .5pt; mso-border-left-themecolor: text1; mso-border-right-themecolor: text1; mso-border-themecolor: text1; mso-border-top-alt: solid black .5pt; mso-border-top-themecolor: text1; padding: 0in 5.4pt 0in 5.4pt; width: 252.9pt;" valign="top" width="337"><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div></td> </tr>
</tbody></table><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">The following Drug approval procedures are only intended for EU member countries and non EU member countries indicated with "*" in the above table.<o:p></o:p></span><br />
<span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="separator" style="clear: both; text-align: center;"></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><div class="separator" style="clear: both; text-align: justify;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEip-abPkXwZwdYegS9zAPQd-sexzFfArEayoo0W0AGJGIZ_HIJaxhhmlyU_l-0HomB1iOliUQcXPhTH1o0Z27DxK7PHkkVY06bsuoj_ahPRE-2sAbIwI913rwURsB2SXnvkYNixwdwssPuc/s1600/drug+approval.JPG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><span style="font-family: inherit;"><img border="0" height="444" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEip-abPkXwZwdYegS9zAPQd-sexzFfArEayoo0W0AGJGIZ_HIJaxhhmlyU_l-0HomB1iOliUQcXPhTH1o0Z27DxK7PHkkVY06bsuoj_ahPRE-2sAbIwI913rwURsB2SXnvkYNixwdwssPuc/s640/drug+approval.JPG" width="640" /></span></a></div><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><b><i>1.Centralised Procedure-</i></b><o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"></div><ul><li style="text-align: justify;"><span style="font-family: inherit;">The centralised procedure, allows applicants to obtain a marketing authorisation that is valid throughout the EU (27 EU member countries).</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">Application to market a medicinal product that is eligible for the centralised procedure is sent to European Medicines Agency (EMA) which is assessed by the Committee for Medicinal Products for Human Use (CHMP)</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">The time limit for the evaluation procedure is 210 days</span></li>
</ul><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">Centralised procedure is <b>mandatory</b> for the following-<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"></div><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">Medicinal products manufactured using biotechnological processes like recombinant DNA, Hybridoma technology, controlled gene expression, tissue-engineering.</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">Orphan medicinal products</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">Products containing a new active substance which was not authorised in the Community before 20 May 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes</span></li>
</ul><div style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"></div><div style="text-align: justify;"><span style="font-family: inherit;">Centralised procedure is <b>optional</b> for the following-</span></div><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;"> New active substances not authorised in the Community before 20 May 2004</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">Products which constitute a significant therapeutic, scientific or technical innovation or for which a Community authorisation is in the interests of patients or animal health at Community level.</span></li>
</ul><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><i><b>2. Decentralised Procedure-</b></i><o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"></div><ul><li style="text-align: justify;"><span style="font-family: inherit;">The decentralised procedure is used for products that have not yet received authorisation in an EU country.</span></li>
</ul><div style="text-align: justify;"><b><span style="font-family: inherit;">Outline of Decentralised Procedure are-</span></b></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">(i) Pre-procedural Step<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">(ii) Assessment step I<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">(iii) Assessment step II<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">(iv) National step</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><i><b><span style="font-family: inherit;">Involved members/groups in DCP-</span></b></i></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><i><b><span style="font-family: inherit;">RMS- Reference member state</span></b></i><br />
<span style="font-family: inherit;">RMS has the following roles-</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-Acts as a link between the applicant (Pharma Company) and the CMSs<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-Allocation of procedure number<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-Starting the procedure<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-Involved in the preparation of preliminary and draft-assessment reports, initial comments on- SmPC (summary of product characteristics), labeling and package leaflets provided in the dossier.</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-Stopping and restarting the procedure, before and after clock stop period.<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-Closing the procedure if consensus is reached.<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><b><i>CMS(s)-Concerned member state(s)</i></b><o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-Involved in the approval/disapproval of RMS’s - preliminary and draft-assessment reports, initial comments on SmPC (summary of product characteristics), labeling and package leaflets <o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-Involved in earlier stages of DCP to avoid disagreements between CMS and RMS.</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><i><b>The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)</b></i><o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">CMDh has following responsibilities-<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-In case of disagreement between the Member States involved in a Mutual recognition or decentralised procedure on the Assessment report, the summary of product characteristics, the labelling or the package leaflet on the grounds of “potential serious risk to public health”, the points of disagreement are considered by the CMDh. The CMDh uses its best endeavours to reach agreement on the action to be taken within the 60 day time period foreseen in the legislation.<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-To lay down, yearly, a list of medicinal products for which a harmonised summary of product characteristics should be drawn up, to promote harmonisation of marketing authorisations across the Community.</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><b><i>The Committee for Medicinal Products for Human Use (CHMP)-</i></b><o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">If consensus is not reached at CMDh the points of disagreement will be referred to CHMP.</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><b><i>Note: </i></b><o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">-RMS and CMSs are the countries where the applicant (pharma companies) intends to get marketing approval for its products<o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">- CMDh and/or CHMP are only involved if there is disagreement between RMS and CMSs.</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span class="Apple-style-span" style="color: red; font-family: inherit;"><a href="http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/DCP/CMDh-080-2005-Rev1_Clean_2010_05.pdf">FLOWCHART OF DECENTRALISED PROCEDURE</a></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><b><i>3. Mutual Recognition Procedure-</i></b><o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"></div><ul><li style="text-align: justify;"><span style="font-family: inherit;">The mutual recognition procedure is used for products that have already received authorisations in one or more EU countries.</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">The mutual recognition procedure is based on the principle of the mutual recognition by EU Member States of their respective national marketing authorisations.</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">The drug should already be approved in the selected RMS.</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">The time period for the procedure is less than DCP and CP.</span></li>
</ul><div><div style="text-align: justify;"><span class="Apple-style-span" style="color: cyan; font-family: inherit;"><a href="http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/MRP/CMDh_081_2007-Rev1-Clean-2011_11.pdf">FLOW CHART OF MUTUAL RECOGNITION PROCEDURE</a></span></div></div><div><div style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div></div><div><div style="text-align: justify;"><span style="font-family: inherit;">Note : Information on RMS, CMS, CMDh and CHMP is as that provided in DCP.</span></div></div><div style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;"><i><b>4. National Procedure-</b></i><o:p></o:p></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"></div><ul><li style="text-align: justify;"><span style="font-family: inherit;">It is limited to the initial phase of mutual recognition procedure</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">If the drug product is intended to be authorized in only one EU member state.</span></li>
</ul><ul><li style="text-align: justify;"><span style="font-family: inherit;">Generally, not used now-a days.</span></li>
</ul><div style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div style="text-align: justify;"><b><i><span style="font-family: inherit;">Advantages of Drug approval procedures (CP, DCP, MRP)-</span></i></b></div><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">The applicant need not go through the entire cycle of Dossier filing-------Queries-------Reply to queries--------Approval in all the EU member countries.</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">Approval in multiple countries through single procedure</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">Time of approval in various EU member countries can be minimised</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: inherit;">Costs can be reduced</span></li>
</ul><div style="text-align: justify;"><div class="MsoNormal"><span style="font-family: inherit; line-height: 115%;"><b><i>Note-</i></b></span><br />
<span style="font-family: inherit; line-height: 115%;"><b><i><br />
</i></b></span></div><div class="MsoNormal"><span style="font-family: inherit; line-height: 115%;">- Any product registered in France can be marketed in Monaco too, as Monaco delegated its responsibility of Drug approval to France.<o:p></o:p></span></div><div class="MsoNormal"><span style="font-family: inherit; line-height: 115%;"><br />
</span></div><div class="MsoNormal"><span style="font-family: inherit; line-height: 115%;">-Any product authorized in the UK can be automatically sold in the Channel Islands (legally not part of the UK, but owes allegiance to the British Crown)</span><br />
<span style="font-family: inherit; line-height: 115%;"><br />
</span><br />
<span style="font-family: inherit; line-height: 115%;">-Iceland has applied for EU membership</span><br />
<span style="font-family: inherit; line-height: 115%;"><br />
</span><br />
<span style="font-family: inherit; line-height: 115%;"><b>Keywords- </b>EU, CP, DCP, MRP, NP, RMS, CMS, CMDh, CHMP.</span><br />
<span style="font-family: inherit; line-height: 115%;"><br />
</span></div></div><div style="text-align: justify;"><span style="font-family: inherit;"><br />
</span></div><div style="text-align: justify;"><b><i><span style="font-family: inherit;">References-</span></i></b></div><div style="text-align: justify;"><span style="font-family: inherit;">1.<a href="http://ec.europa.eu/health/authorisation-procedures-centralised_en.htm" style="text-align: justify;">http://ec.europa.eu/health/authorisation-procedures-centralised_en.htm</a></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span style="font-family: inherit;">2.<a href="http://www.bfarm.de/EN/drugs/2_Authorisation/types/euAuthProcs/cp/central-node-en.html">http://www.bfarm.de/EN/drugs/2_Authorisation/types/euAuthProcs/cp/central-node-en.html</a></span><br />
<span style="font-family: inherit;">3.<a href="http://ec.europa.eu/health/authorisation-procedures-mutual-recognition_en.htm">http://ec.europa.eu/health/authorisation-procedures-mutual-recognition_en.htm</a></span><br />
<span style="font-family: inherit;">4.<a href="http://www.hma.eu/47.pdf">http://www.hma.eu/47.pdf</a></span><br />
<span style="font-family: inherit;">5.<a href="http://wiki.answers.com/Q/Which_European_countries_are_not_in_the_European_Union">http://wiki.answers.com/Q/Which_European_countries_are_not_in_the_European_Union</a></span></div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><b><i><span style="font-family: inherit;">Further reading-</span></i></b><br />
<span style="font-family: inherit;">1. <a href="http://ec.europa.eu/health/files/eudralex/vol-2/a/chap4rev200604_en.pdf">http://ec.europa.eu/health/files/eudralex/vol-2/a/chap4rev200604_en.pdf</a></span><br />
<span style="font-family: inherit;">2.<a href="http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_chap2_2007-02_en.pdf">http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a_chap2_2007-02_en.pdf</a></span><br />
<span style="font-family: inherit;">3.<a href="http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/DCP/CMDh-078-2005-Rev3-Clean_2011_09.pdf">http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/DCP/CMDh-078-2005-Rev3-Clean_2011_09.pdf</a></span></div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com7tag:blogger.com,1999:blog-7538891640847716324.post-21629215952296263022011-11-13T19:16:00.000+05:302011-11-13T19:16:13.288+05:30FDA Form 483<div dir="ltr" style="text-align: left;" trbidi="on"><br />
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<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgnXlU0SzxVPy90o08X0xt6DwNgh0QlRyzzfczYPRe3jOpB6K6zGAgGr9KIjD3uxA9qpeYaG3tuzOeLFQK0QuMPIlmm9nlygx_ef8o0avJ4dhN0ZZ-QdQB6dB_AMv82X3FmM7sWdc_QOM2B/s1600/form+483.JPG" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="235" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgnXlU0SzxVPy90o08X0xt6DwNgh0QlRyzzfczYPRe3jOpB6K6zGAgGr9KIjD3uxA9qpeYaG3tuzOeLFQK0QuMPIlmm9nlygx_ef8o0avJ4dhN0ZZ-QdQB6dB_AMv82X3FmM7sWdc_QOM2B/s400/form+483.JPG" width="400" /></a></div><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><br />
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<div class="MsoNormal" style="margin-bottom: 0in; text-align: justify;"></div><div class="MsoNormal" style="margin-bottom: 6pt;"></div><div class="MsoNormal"><div style="text-align: justify;">Here is a post on Form-483, which is dreaded by managements of pharmaceutical companies!</div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><b><i><br />
</i></b></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><b><i>What is Form-483?</i></b><o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, "Factory Inspection". FDA Form 483 “Inspectional Observations,” is a form used by the FDA to document and communicate concerns discovered during these inspections. It is also referred to as "Form 483 or merely 483.<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"> <b><i>In simple words</i></b>- “It is a form which consists of all the objectionable observations by a FDA inspector during his/her inspection of manufacturing facility (Pharmaceuticals manufacturing facility in the present context)”<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><br />
</span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><b><i>When is a FDA Form 483 issued? </i></b><o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgement, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><br />
</span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"> <b><i>What is the purpose of an FDA Form 483? </i></b><o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><br />
</div></div><div class="MsoNormal"><div style="text-align: justify;"><b><i><span class="Apple-style-span" style="font-family: inherit;">Is the FDA Form 483 intended to be an all-inclusive list of every possible deviation from law and regulation?<o:p></o:p></span></i></b></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">No, it’s not. The FDA Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection. There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483. FDA investigators are instructed to note only what they saw during the course of the inspection. Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist.<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><o:p> </o:p> </span></div></div><div class="MsoNormal"><div style="text-align: justify;"><b><i><span class="Apple-style-span" style="font-family: inherit;">What are the implications of the FDA Form 483 for agency enforcement and what happens next?</span></i></b></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. The FDA Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><br />
</div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><b><i>Disclaimers in form 483-</i></b><o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">"This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.”<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><br />
</span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">"The observations noted in this Form FDA-483 [sic] are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements."<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><br />
</div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><b><i>Recent trends in form-483-</i></b><o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">From 2002 to 2009, the dominant problem area documented on Form FDA 483 was Investigations, which are integral to good CAPA programs. Investigations accounted for 27% of the observations in 2009. The next most problematic areas were Equipment/Facilities/Operations at 11% (2009) and Validation at 10% (2009).<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">The FDA issued 9,910 483s in 2010, which is at least a 10-year high based on available data. Among these, the top three issues were quality unit deficiencies, inadequate batch failure investigations, and lack of follow-up procedures. For international inspections, the top three were deficient laboratory controls, quality unit deficiencies, and deficient procedures.<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><br />
</span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><a href="http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/default.htm">The link for accessing Form 483’s issued by FDA</a><o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><br />
</div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">References-<o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><a href="http://en.wikipedia.org/wiki/Form_483">http://en.wikipedia.org/wiki/Form_483</a><o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><a href="http://www.fda.gov/ICECI/EnforcementActions/ucm256377.htm">http://www.fda.gov/ICECI/EnforcementActions/ucm256377.htm</a><o:p></o:p></span></div></div><div class="MsoNormal"><div style="text-align: justify;"><br />
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</div><div style="text-align: justify;"></div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com7tag:blogger.com,1999:blog-7538891640847716324.post-44093333246288795992011-11-03T17:24:00.002+05:302012-03-19T13:18:41.853+05:30Effective Dossier Management<div dir="ltr" style="text-align: left;" trbidi="on"><div style="text-align: justify;"><b><i><br />
</i></b></div><div class="separator" style="clear: both; text-align: center;"></div><div class="separator" style="clear: both; text-align: justify;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi3Vrz-Eo7-j_wKH-hfbW7C2QK47T9UHoVp346Cp7WBTAzD5tgz4PsAYhFFiap8MpXNy7WpF8nMhHCr0M-cvdkJzIzDw_g_IakarUB6D0wlJh1dQA5GTHxjn_fauaZucfF8X9RRinqe_w40/s1600/doss1.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi3Vrz-Eo7-j_wKH-hfbW7C2QK47T9UHoVp346Cp7WBTAzD5tgz4PsAYhFFiap8MpXNy7WpF8nMhHCr0M-cvdkJzIzDw_g_IakarUB6D0wlJh1dQA5GTHxjn_fauaZucfF8X9RRinqe_w40/s320/doss1.bmp" width="320" /></a></div><div style="text-align: justify;"><b><i><br />
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</i></b></div><div style="text-align: justify;"><b><i>Importance of effective dossier management-</i></b></div><ul style="text-align: left;"><li style="text-align: justify;">The registration dossier for medicines is an important document which is submitted for review to regulatory agencies by pharma companies for approval to market their medicines.</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"> Utmost care should be taken during its compilation and filing as it plays a direct role in earliest possible availability of medicines in the market which in turn translates into business for the company.</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">Of course, regulatory affairs professionals need to ensure the safety, quality and efficacy of the medicines for which they are filing registration dossier.</li>
</ul><div style="text-align: justify;">Note : The dossiers could be anything among DMF, ASMF, ANDA, NDA or MAA.</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">From my experience I could possibly think of 3 important aspects which play an important role in effective dossier management-</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">1. Planning aspects</div><div style="text-align: justify;">2. Formatting and compilation aspects</div><div style="text-align: justify;">3. Review aspects</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><b><i>1. Planning </i></b><b><i>aspects-</i></b></div><ul style="text-align: left;"><li style="text-align: justify;"><b>Deadline</b>-It is important to know the deadline for filing the dossier and action plan should be prepared so as to meet the deadline.</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><b>Understanding the registration requirements of respective agencies- </b>Although most of the regulatory agencies accept the CTD format for registration dossier, the requirements for approving marketing applications may vary for individual agencies. For example- USFDA requires Batch Manufacturing Records to be provided, while it is not necessary for approval by European regulatory agencies. Hence it is necessary to completely read and understand the guidance document of each regulatory agency before going ahead with filing registration dossier with them. </li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><b>Requirements Listing</b>- Listing down all the requirements for preparing the registration dossier, for example in the preparation of section 3.2.S.1 of a DMF I need to have all the information on nomenclature, structure and general properties (like pH, Pka, solubility, partition coefficient, stereochemistry etc ) of drug substance. Similarly Listing down all the requirements for preparation of all the modules and their respective sections is an important aspect.</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><b>Sending the requirements list to respective departments</b><i>-</i>Preparing an individual requirement list and sending them to each respective department. For example I need to have all the information regarding the general properties, synthetic scheme, manufacturing process development of drug from R & D department and finalised specification & test procedures, Batch manufacturing sheets from Quality assurance department.</li>
</ul><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><b><i>2. Formatting and Compilation Aspects-</i></b></div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><b>Format-</b></div><div style="text-align: justify;"><b><br />
</b></div><div style="text-align: justify;">As per the ICH's M4 guideline the following are recommended-</div><div style="text-align: justify;"><ul><li>The display of information should be unambiguous and transparent, in order to facilitate the review of the basic data and to help a reviewer become quickly oriented to the application contents.</li>
</ul><ul><li>Text and tables should be prepared using margins that allow the document to be printed on both A4 and 8.5 x 11” paper (For Europe and Japan regions A4 paper is recommended and 8.5 x 11” paper for USA).</li>
</ul><ul><li>Times New Roman, 12-point font is recommended for narrative text.</li>
</ul><ul><li>The left-hand margin should be sufficiently large that information is not obscured by the method of binding.</li>
</ul><ul><li>Font sizes for text and tables should be of a style and size that are large enough to be easily legible, even after photocopying.</li>
</ul><ul><li>Every page should be numbered, according to the granularity document (refer pages 6 to 14 of <a href="http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R3_Organisation/M4_R3__organisation.pdf">M4 guideline</a>).</li>
</ul><div class="MsoNormal"></div><ul><li>Acronyms and abbreviations should be defined the first time they are used in each module.</li>
</ul><ul><li>References should be cited in accordance with the current edition of the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, International Committee of Medical Journal Editors (ICMJE).</li>
</ul><ul><li>All pages of a document should include a unique header or footer that briefly identifies its subject matter.</li>
</ul><div>Note: For any person who is new/relatively new to the field of RA it is important to read and understand CTD guidelines of ICH (M4, M4Q,M4S, M4E) before starting to compile any dossier. (Refer the post <a href="http://www.regulatoryone.com/2011/10/ctd.html">CTD</a> in my blog)</div><div><br />
</div><div><b><i>Compilation-</i></b></div><div><b><i><br />
</i></b></div></div><div style="text-align: justify;">The following compilation aspects are important-</div><div style="text-align: justify;"><ul><li>The information should be specific, clear, precise and accurate.</li>
</ul><ul><li>Typographical and grammatical errors should be avoided.</li>
</ul><ul><li>The information should be arranged in a sequential order in computer. Each module could have a separate folder and in turn each section of a module could have a separate folder. This kind of orderly arrangement will help in easy access of information and help in taking printouts of finalized copy conveniently.</li>
</ul><ul><li>The line spacing should be preferably single.</li>
</ul><ul><li>All the documents received from other departments should be cross-checked so as to ensure that they are free from errors.</li>
</ul><ul><li>Ensuring the specifications & test procedures are designed in accordance with ICH guidelines Q3A, Q3B, Q3C, Q6A and Q6B. Stability Protocols are designed as per ICH guidelines Q1A through Q1E . Similarly ensuring that various documents are designed as per ICH guidelines. This can be ensured during drafting stages of preparation of various documents.</li>
</ul><ul><li>After the finalized soft copy is ready, printouts should be taken using a good quality printer and arranged sequentially in a module and section wise manner. </li>
</ul><ul><li>As per the note given in the website of <a href="http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp&jsenabled=true">EMA</a>-"All Microsoft Office documents submitted to the European Medicines Agency must be in a format compatible with MS Office 2003. Office 2007 and Office 2010 formats cannot currently be accepted".</li>
</ul><div><br />
</div><div><b><i>3.Review Aspects</i></b></div></div><ul style="text-align: left;"><li style="text-align: justify;">.Every human being is prone to make mistakes; hence it is important to <b>re check</b> the information in the dossier before filing it with regulatory agencies. </li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">It is also important that a dossier meant to be filed with a regulatory agency should be <b>cross verified</b> by a person other than the one who has complied the dossier.</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">It is very useful to have a <b>check list</b> so as to ensure that all the required information is present in the dossier before submission to regulatory agency.</li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">The USFDA has a check list which is very useful while filing an ANDA- <a href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM151259.pdf">ANDA checklist</a></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;">The module 1 of CTD in most of the cases is completely different for various agencies hence care should be taken in compiling this section.</li>
</ul><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><b><i>Avoiding Deficiencies-</i></b></div><div style="text-align: justify;">You can learn without necessarily making mistakes. EDQM has compiled a list of <a href="http://www.edqm.eu/medias/fichiers/cep_top_ten_deficiencies_new_applications.pdf">top 10 deficiencies of CEP dossier</a> which will go a long way in preventing you from making the same mistakes.</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><b><i>Key software skills for effective dossier management-</i></b></div><div style="text-align: justify;"></div><ul><li style="text-align: justify;">Proficiency in <b>MS office</b> (Yes, I know that most of you are proficient! ).</li>
</ul><ul><li style="text-align: justify;">Proficiency in <b>Adobe Acrobat tools</b>. (Especially useful in preparing NeeS dossier and eCTD ).</li>
</ul><ul><li style="text-align: justify;">Proficiency in <b>ISIS draw</b> or <b>Chem sketch</b> softwares, which are useful in drawing chemical structures.</li>
</ul><ul><li style="text-align: justify;">Since we generally receive number of mails on a daily basis, we could sort the emails by using labels based on the sources. This will make your job easy while accessing mails.</li>
</ul><ul><li style="text-align: justify;">eCTD is mandatory for the centralised procedures in Europe and it could be made mandatory for the other procedures as well in the future. Hence it is important to undergo training in the use of <b>eCTD software</b>.(My fellow Indian countrymen, let me know if there are any institutes which are offering training in the use of eCTD software back here in India)</li>
</ul><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><b>P.S</b>- </div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">1. This article is mainly intended to provide guidance for the preparation of paper format of registration dossier, but not eCTD or NeeS format.</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">2. I have posted this article based on my experiences. There could be other key aspects which are to be considered in preparation of registration dossier for medicines.</div><div style="text-align: justify;"><br />
<b>Keywords- </b>registration dossier, planning aspects, formatting and compilation aspects, review aspects, M4, M4Q, ANDA check list.<br />
<br />
</div><div style="text-align: justify;">References :</div><div style="text-align: justify;"><a href="http://ich.org/">http://ich.org/</a></div><div style="text-align: justify;"><a href="http://www.ema.europa.eu/">http://www.ema.europa.eu/</a></div><div style="text-align: justify;"><a href="http://www.fda.gov/">http://www.fda.gov/</a></div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><br />
</div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com7tag:blogger.com,1999:blog-7538891640847716324.post-66464114574321095402011-11-03T17:19:00.006+05:302012-03-19T13:20:18.976+05:30Orange Book<div dir="ltr" style="text-align: left;" trbidi="on"><div class="separator" style="clear: both; text-align: justify;"> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmh0ZSUoxKnPfCrIYcWGpVLODFaHGSjYHjaaSTXHAagjjHB_Wvui9SKsgT2I6QPb2QT6siVDhe2OGD1PvSgojHEaasKrPIglgIs4gLAwShG_C3TkMa78Dwakt-KVefl0CMZOlpRcRAsr1b/s1600/untitled.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgmh0ZSUoxKnPfCrIYcWGpVLODFaHGSjYHjaaSTXHAagjjHB_Wvui9SKsgT2I6QPb2QT6siVDhe2OGD1PvSgojHEaasKrPIglgIs4gLAwShG_C3TkMa78Dwakt-KVefl0CMZOlpRcRAsr1b/s400/untitled.bmp" width="308" /></a></div><div style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><b><br />
</b></span></div><div style="text-align: justify;"><b><span style="line-height: 115%;"><span class="Apple-style-span" style="font-family: inherit;"><br />
</span></span></b></div><div style="text-align: justify;"><b><span style="line-height: 115%;"><span class="Apple-style-span" style="font-family: inherit;">What is Orange Book?</span></span></b></div><ul style="text-align: left;"><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;">It is the commonly used name for the book “</span><b style="line-height: 18px;">Approved Drug Products with Therapeutic Equivalence Evaluations</b><span class="Apple-style-span" style="line-height: 18px;">”, which is published by USFDA.</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">It contains the list of drug products, approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.</span></span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;">FDA was required to publish orange book under Drug, Price and Competition Act (1984) which is also known as Hatch-Waxman Act</span></li>
</ul><br />
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"></div><div class="MsoNormal" style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><b>Orange book doesn’t cover-</b></span></div><ul style="text-align: left;"><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;">Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal Tablets and Librax Capsules]</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">Pre-1938 drugs [e.g., Phenobarbital Tablets]) are not included in this publication. </span></span></li>
</ul><br />
<div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><b><span style="line-height: 115%;"><span class="Apple-style-span" style="font-family: inherit;">Other important facts-</span></span></b></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"></div><ul><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons.</span></span></li>
</ul><ul><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product.</span></span></li>
</ul><ul><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">The List contains therapeutic equivalence evaluations for approved multisource prescription drug products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs.</span></span></li>
</ul><ul><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act.</span></span></li>
</ul><br />
<div class="MsoNormal" style="text-align: justify;"><span style="line-height: 115%;"><span class="Apple-style-span" style="font-family: inherit;">We can search all the orange book listed approved drug products in the FDA’s website by using any of the following search options</span></span></div><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">Search by Active Ingredient</span></span></li>
<li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">Search by Applicant Holder</span></span></li>
<li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">Search by Proprietary Name</span></span></li>
<li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">Search by Application Number</span></span></li>
<li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">Search by Patent</span></span></li>
</ul><br />
<div style="text-align: justify;"><a href="http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm"><span class="Apple-style-span" style="color: blue;">Search all the FDA approved Drug Products</span></a></div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;"><a href="http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf" style="text-align: left;"><span style="color: blue;"><span class="Apple-style-span" style="font-family: inherit;">Download link for 31st edition of e-orange book</span></span></a></div><div class="MsoNormal" style="margin-bottom: 0.0001pt;"><br />
<div style="text-align: justify;"><b>Keywords:</b> <span style="line-height: 18px; text-align: justify;">Approved Drug Products with Therapeutic Equivalence Evaluations, Orange Book, </span><span class="Apple-style-span" style="line-height: 18px;">Drug, Price and Competition Act or </span><span class="Apple-style-span" style="line-height: 18px;">Hatch-Waxman Act, </span><span class="Apple-style-span" style="line-height: 18px;">DESI.</span></div><br />
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</div><div class="MsoNormal" style="margin-bottom: 0.0001pt;"><span class="Apple-style-span" style="font-family: inherit;"><b>References</b>-</span></div><div class="MsoNormal" style="margin-bottom: 0.0001pt;"><a href="http://www.wikipedia.org/"><span class="Apple-style-span" style="color: blue;">http://www.wikipedia.org/</span></a></div><div class="MsoNormal" style="margin-bottom: 0.0001pt;"><a href="http://www.fda.gov/"><span class="Apple-style-span" style="color: blue;">http://www.fda.gov/</span></a></div><br />
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</div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com6tag:blogger.com,1999:blog-7538891640847716324.post-36079634608985204522011-10-26T23:32:00.004+05:302012-03-19T13:21:37.513+05:30CTD<div dir="ltr" style="text-align: left;" trbidi="on"><div dir="ltr" style="text-align: left;" trbidi="on"><div dir="ltr" style="text-align: left;" trbidi="on"><div dir="ltr" style="text-align: left;" trbidi="on"><div dir="ltr" style="text-align: left;" trbidi="on"><div dir="ltr" style="text-align: left;" trbidi="on"><br />
<div style="margin-bottom: .0001pt; margin: 0in;"><b><i><span style="color: black; font-family: inherit;">What is CTD?</span></i></b><span style="color: black;"><o:p></o:p></span></div><div style="margin-bottom: .0001pt; margin: 0in;"><br />
</div><div class="MsoNormal" style="margin-bottom: 6pt; text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;"><span class="Apple-style-span" style="font-size: small;">The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.</span><span class="apple-style-span">Quality, Safety and Efficacy information is assembled in a common format through CTD<span class="apple-style-span"><span class="Apple-style-span" style="font-size: small;"> .</span></span>The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).</span></span><br />
<span class="Apple-style-span" style="font-family: inherit;"><span class="apple-style-span"><br />
</span></span><br />
<span class="Apple-style-span" style="font-family: inherit;"><span class="apple-style-span">In simple words "<b>CTD is the format for registration of medicines, generally used in EU region, USA and Japan</b>."</span></span><br />
<br />
<b><i>Note :</i></b> CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc. </div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">The Common Technical Document is divided into five modules:<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">1. Administrative information and prescribing information<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">2. Common Technical Document summaries (Overview and summary of modules 3 to 5)<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">3. Quality <o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">4. Nonclinical Study Reports (toxicology studies)<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">5. Clinical Study Reports (clinical studies)</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">The Common Technical Document is better understood with a CTD triangle which is presented below-</span></div><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg-lwLRmShXcCcZEdDTO72_q2KVDq06k0OQMm3ezE657SlJnrayrH4-sd9wvCXYXKmNJ1vhhqZ11O0Mi8BKLqWo-D7kFjHLm9ygqjtnsI3u4fBJ-tGD0acjHZc-v9AnXlNUIwMQVeBJN-yb/s1600/CTD.JPG" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="370" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg-lwLRmShXcCcZEdDTO72_q2KVDq06k0OQMm3ezE657SlJnrayrH4-sd9wvCXYXKmNJ1vhhqZ11O0Mi8BKLqWo-D7kFjHLm9ygqjtnsI3u4fBJ-tGD0acjHZc-v9AnXlNUIwMQVeBJN-yb/s400/CTD.JPG" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Source: ich.org</td></tr>
</tbody></table><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span class="Apple-style-span" style="font-family: 'Times New Roman', serif;"><br />
</span></div><div class="MsoNormal" style="text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">The CTD is the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the FDA. Apart from EU region, USA and Japan, CTD format is widely accepted by many regulatory agencies across the world for registration of Medicines.<o:p></o:p></span></div><div style="margin-bottom: .0001pt; margin: 0in;"><br />
</div><div style="margin-bottom: .0001pt; margin: 0in;"><span style="color: black;"><o:p> </o:p></span><b><i><span class="Apple-style-span" style="font-family: inherit;">What are the advantages due to the use of CTD?</span></i></b></div><div style="margin-bottom: .0001pt; margin: 0in;"><span style="color: black;"><o:p></o:p></span></div><div class="MsoNormal"></div><ul style="text-align: left;"><li><span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px; line-height: 18px;">It has revolutionised the regulatory review processes</span></li>
</ul><ul style="text-align: left;"><li><span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px; line-height: 18px;">It led to harmonised electronic submission which, in turn, enabled implementation of good review practices</span></li>
</ul><ul style="text-align: left;"><li><span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px; line-height: 18px;">For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities</span></li>
</ul><div><span class="Apple-style-span" style="font-family: 'Times New Roman', serif;"><span class="Apple-style-span" style="line-height: 18px;"><br />
</span></span></div><div><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="font-family: inherit;">All the ICH guidelines related to CTD (M4, M4Q, M4S, M4E) are presented below-</span></span></div><div><span class="Apple-style-span" style="font-family: 'Times New Roman', serif;"><span class="Apple-style-span" style="line-height: 18px;"><br />
</span></span></div></div><span class="Apple-style-span"><u>M4 Guideline of ICH</u>- </span><span class="Apple-style-span" style="font-family: inherit;">This gives a complete information on the organisation of CTD</span><br />
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In the above guideline to get a complete idea on the sections under each module you need to focus on the content in the page- 5<br />
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</div><span id="goog_190581331"></span><u>M4Q Guideline of ICH</u><span id="goog_190581332"></span>-<span class="Apple-style-span" style="color: #444444; font-size: medium;"><span class="Apple-style-span" style="line-height: 20px;"> </span></span><span class="Apple-style-span" style="font-family: inherit;">This provides harmonised structure and format for presenting CMC (Chemistry, Manufacturing and Controls) information in a registration dossier.</span><br />
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<iframe class="scribd_iframe_embed" data-aspect-ratio="0.706697459584296" data-auto-height="true" frameborder="0" height="600" id="doc_60974" scrolling="no" src="http://www.scribd.com/embeds/70354794/content?start_page=1&view_mode=list&access_key=key-3yo36sg0vkbk3b6ktdm" width="100%"></iframe><br />
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</div><span class="Apple-style-span" style="font-family: Helvetica, Arial, sans-serif; font-size: 14px;"><u>M4S Guideline of ICH</u>- </span><span class="Apple-style-span" style="color: black; font-family: inherit; font-size: small;">This provides information on the non-clinical section of application</span><br />
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<u><iframe class="scribd_iframe_embed" data-aspect-ratio="1" data-auto-height="true" frameborder="0" height="600" id="doc_47251" scrolling="no" src="http://www.scribd.com/embeds/70354856/content?start_page=1&view_mode=list&access_key=key-2ciea7reutn2rrrycodj" width="100%"></iframe></u><script type="text/javascript">
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<u>M4E Guideline of ICH</u>- This provides information on the clinical section of application.<br />
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<b>Keywords</b>: CTD, <span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px;">CTD triangle, </span>Quality, Safety , Efficacy,<span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px;"> </span><span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px;"> </span><span class="Apple-style-span" style="line-height: 18px;">M4, M4Q, M4S, M4E.</span><br />
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<b>References: </b><br />
<a href="http://www.wikipedia.org/">http://www.wikipedia.org/</a><br />
<a href="http://ich.org/">http://ich.org/</a></div><script type="text/javascript">
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</div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com3tag:blogger.com,1999:blog-7538891640847716324.post-1314679563166534922011-10-24T17:28:00.002+05:302012-03-19T13:23:14.016+05:30ICH Guidelines<div dir="ltr" style="text-align: left;" trbidi="on"><br />
The guidelines of ICH may be broadly categorized into four types-<br />
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Quality Guidelines<br />
Safety Guidelines<br />
Efficacy Guidelines<br />
Multidisciplinary Guidelines<br />
<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiYbd9y8UjvW0EsZZpNaMXy9DlAMNu_6AoP_2BPLZ6w4zoCvTxGdXJogobYMMS8Xe9g22kGEudJi2zfs4c6eKDzgOzHRuUv3VRJtNKBcUyay17FxP0lKckDGEalcKuh8CmKrYZgGmkJsIUC/s1600/q-big_05.png" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><span class="Apple-style-span" style="-webkit-text-decorations-in-effect: none; color: black;"></span><span class="Apple-style-span" style="-webkit-text-decorations-in-effect: none; color: black;"></span><span class="Apple-style-span" style="-webkit-text-decorations-in-effect: none; color: black;"></span></a></div><br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi8BQ0w6zM8u_Ula0h9BWx4GlrpzCmAcUQVlv3zbj-6fhn_85ffJbZ-RMcEnFllWeBFKcPKj_Bzusvsv2Bd5Gyq6qg7fem6bNMB16sdKi5AYtr6zvnOahq08obt3MqNtW8O992n-LpkSQVk/s1600/Untitled.png" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="223" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi8BQ0w6zM8u_Ula0h9BWx4GlrpzCmAcUQVlv3zbj-6fhn_85ffJbZ-RMcEnFllWeBFKcPKj_Bzusvsv2Bd5Gyq6qg7fem6bNMB16sdKi5AYtr6zvnOahq08obt3MqNtW8O992n-LpkSQVk/s400/Untitled.png" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Source: ich.org</td></tr>
</tbody></table><br />
<div style="text-align: justify;">Quality Guidelines : Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">Safety Guidelines : ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">Efficacy Guidelines : The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines.</div><div style="text-align: justify;"><br />
</div><div style="text-align: justify;">Multidisciplinary Guidelines : Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).</div><div style="text-align: justify;"><br />
<b>Keywords</b>: Quality Guidelines, Safety Guidelines, Efficacy Guidelines, Multidisciplinary Guidelines, CTD, ESTRI, MedDRA.<br />
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<b>Reference</b> : <a href="http://www.ich.org/">http://www.ich.org/</a></div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com11tag:blogger.com,1999:blog-7538891640847716324.post-1000643762053551832011-10-20T18:58:00.001+05:302012-03-19T13:24:51.204+05:30ICH<div dir="ltr" style="text-align: left;" trbidi="on"><div class="separator" style="clear: both; text-align: center;"></div><div class="separator" style="clear: both; text-align: center;"></div><div class="separator" style="clear: both; text-align: center;"></div><div class="separator" style="clear: both; text-align: center;"></div><div class="separator" style="clear: both; text-align: center;"></div><div class="separator" style="clear: both; text-align: center;"></div><div class="separator" style="clear: both; text-align: center;"></div><br />
<table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhOCXXoxZXlcpPPzMJvnTohiIhTB87vCS29TSq5t4gGRe8_k0A63yIKjfYSoNhsa6nIr1YfV8gfx992zNeIVtXZTkqFtVbD8xlAEr5tjfXHobvMwM7a7O8JHbXCutaSNAy-AqPEnqU-faE1/s1600/ICH_logo.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="140" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhOCXXoxZXlcpPPzMJvnTohiIhTB87vCS29TSq5t4gGRe8_k0A63yIKjfYSoNhsa6nIr1YfV8gfx992zNeIVtXZTkqFtVbD8xlAEr5tjfXHobvMwM7a7O8JHbXCutaSNAy-AqPEnqU-faE1/s400/ICH_logo.jpg" width="400" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Source: ich.org</td></tr>
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<div class="MsoNormal"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">What is ICH?</span></i></b></div><div class="MsoNormal"><span style="font-size: 12pt; line-height: 115%;"></span></div><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;">ICH is <b><i>The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.</i></b></li>
</ul><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;">It is unique project that brings together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.</li>
</ul><div class="MsoNormal"></div><ul style="text-align: left;"><li style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">It was formed to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration in EU, Japan and US<span class="Apple-style-span" style="color: #444444;"><span class="Apple-style-span" style="line-height: 18px;">A</span></span></span></li>
</ul><div class="MsoNormal"><br />
</div><div class="MsoNormal" style="text-align: justify;">In Simple words " <b><i>ICH was formed to have a common scientific and technical requirements for registration of pharmaceuticals in EU, Japan and USA to make the job easy for Regulatory agencies and Pharma companies</i>"</b>. </div><br />
<span class="Apple-style-span" style="color: #444444; font-family: inherit;"><span class="Apple-style-span" style="line-height: 18px;"><span style="font-size: 11pt; line-height: 115%;"><b><i>Benefits of Harmonisation/Benefits due to the formation of ICH-</i></b></span></span></span><br />
<span class="Apple-style-span" style="color: #444444; font-size: 15px; line-height: 17px;"></span><br />
<div class="MsoNormal" style="display: inline !important;">Harmonisation is beneficial to both regulatory authorities and the pharmaceutical industry, ultimately having beneficial impact for the protection of public health. The benefits of harmonization are listed below-</div><br />
<ul style="text-align: left;"><li style="text-align: justify;"><span class="Apple-style-span" style="color: #444444; font-family: inherit;"><span class="Apple-style-span" style="line-height: 17px;"><span style="line-height: 115%;">Preventing duplication of clinical trials in humans and minimising the use of animal testing without compromising safety and effectiveness.</span></span></span></li>
<li style="text-align: justify;"><span class="Apple-style-span" style="color: #444444; font-family: inherit;"><span class="Apple-style-span" style="line-height: 17px;"><span style="line-height: 115%;"><span style="line-height: 115%;">Harmonisation would lead to a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health</span></span></span></span></li>
<li><span class="Apple-style-span" style="color: #444444; font-family: inherit;"><span class="Apple-style-span" style="line-height: 17px;"><span style="line-height: 115%;"><span style="line-height: 115%;"><div class="MsoNormal" style="text-align: justify;">Streamlining the regulatory assessment process for new drug applications; and reducing the development times and resources for drug development.</div><div class="MsoNormal"><br />
</div></span></span></span></span></li>
</ul><div class="MsoNormal" style="tab-stops: 176.25pt; text-align: justify; text-justify: inter-ideograph;"><span class="apple-style-span"><span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial; color: #444444; font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"><o:p></o:p></span></span></div><span class="Apple-style-span" style="font-family: inherit;"><b><i>Origin Of ICH-</i></b></span><br />
<ul style="text-align: left;"><li style="text-align: justify;">Harmonisation of regulatory requirements was pioneered by the European Community (EC), in the 1980s, as the EC (now the European Union) moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonisation was feasible.</li>
<li style="text-align: justify;"><span style="line-height: 115%;"><span class="Apple-style-span" style="font-family: inherit;">At the same time there were bilateral discussions between Europe, Japan and the US on possibilities for harmonisation. </span></span></li>
<li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;">It was, however, at the WHO Conference of Drug Regulatory Authorities (ICDRA), in Paris, in 1989, that specific plans for action began to materialize.</span></li>
<li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;">Soon afterwards, the authorities approached IFPMA to discuss a joint regulatory-industry initiative on international harmonisation, and ICH was conceived.</span></li>
<li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 18px;"><span style="line-height: 115%;"><span class="Apple-style-span" style="font-family: inherit;"><b>The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels.</b> Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH.</span></span></span></li>
<li><span class="Apple-style-span" style="line-height: 18px;"><span style="line-height: 115%;"><span class="Apple-style-span" style="font-family: inherit;"><div class="MsoNormal" style="text-align: justify;"><span class="Apple-style-span" style="font-family: inherit;">At the first ICH Steering Committee (SC) meeting of ICH the Terms of Reference were agreed and it was decided that the Topics selected for harmonisation would be divided into Safety, Quality and Efficacy to reflect the three criteria which are the basis for approving and authorising new medicinal products</span>.</div></span></span></span></li>
</ul><span class="Apple-style-span" style="line-height: 18px;"></span><br />
<div class="MsoNormal"></div><div class="MsoNormal" style="tab-stops: 176.25pt; text-align: justify; text-justify: inter-ideograph;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="color: #444444; font-family: inherit;"><b><i>ICH Secretariat-</i></b></span></span><br />
<span class="Apple-style-span" style="font-family: inherit;"><span class="Apple-style-span" style="line-height: 18px;"><span class="Apple-style-span" style="color: #444444;">ICH does not have "offices" as such, but <b>ICH secretariat is based in Geneva</b>, Switzerland. </span></span>The biannual meetings and conferences of the ICH Steering Committee rotate between the EU, Japan, and the USA<span class="Apple-style-span" style="color: #444444;"><span class="Apple-style-span" style="line-height: 14px;">.</span></span></span><br />
<div class="MsoNormal"><span class="apple-style-span"><span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial; color: #444444; font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"><o:p></o:p></span></span></div><span class="Apple-style-span" style="color: #444444; font-family: 'Times New Roman', serif;"><span class="Apple-style-span" style="line-height: 18px;"><b><i><br />
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<span class="Apple-style-span" style="color: #444444; font-family: 'Times New Roman', serif;"><span class="Apple-style-span" style="line-height: 18px;"><b><i><br />
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<span class="Apple-style-span" style="color: #444444; font-family: 'Times New Roman', serif;"><span class="Apple-style-span" style="line-height: 18px;"><b><i><br />
</i></b></span></span></div><div class="MsoNormal" style="tab-stops: 176.25pt; text-align: justify; text-justify: inter-ideograph;"><span class="Apple-style-span" style="line-height: 18px;"><span class="apple-style-span"><b><i><span style="background-attachment: initial; background-clip: initial; background-color: white; background-image: initial; background-origin: initial; color: #444444; font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"></span></i></b></span></span></div><div class="MsoNormal"><span class="Apple-style-span" style="line-height: 18px;"><b><i>Members of ICH-</i></b></span></div><div class="MsoNormal"><span class="Apple-style-span" style="line-height: 18px;"><b><i><br />
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<div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgTqxHqx0KZ1LTeqXvLWJ1upyC6rWgopwrQlSRm9VgDZWcpiz3OJvlNCTmxlqjnUCtxC9nJN4XWFTUzaQfV3sIw6pYmoPfBbmdfKO8lUgsVyx3dKCecpNZlZzDDOh3wjbnUlYduywTwcfwM/s1600/members.JPG" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" height="280" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgTqxHqx0KZ1LTeqXvLWJ1upyC6rWgopwrQlSRm9VgDZWcpiz3OJvlNCTmxlqjnUCtxC9nJN4XWFTUzaQfV3sIw6pYmoPfBbmdfKO8lUgsVyx3dKCecpNZlZzDDOh3wjbnUlYduywTwcfwM/s640/members.JPG" width="640" /></a></div><div class="MsoNormal" style="tab-stops: 176.25pt; text-align: justify; text-justify: inter-ideograph;"><span class="Apple-style-span" style="color: #444444; font-family: 'Times New Roman', serif;"><span class="Apple-style-span" style="line-height: 18px;"><b><i><br />
</i></b></span></span></div><div class="MsoNormal"></div><div class="MsoNormal"><b>MHLW<i> </i></b>- Ministry of Health, Labour and Welfare</div><div class="MsoNormal"><b>JPMA</b>- Japan Pharmaceutical Manufacturers Association</div><div class="MsoNormal"><b>EU</b>- European Union </div><div class="MsoNormal"><b>EFPIA</b>- European Federation of Pharmaceutical Industries and Associations </div><div class="MsoNormal"><b>FDA</b>- Food and Drug Administration</div><div class="MsoNormal"><b>PhRMA</b> -Pharmaceutical Research and Manufacturers of America</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">MHLW and JPMA are from Japan<br />
EU and EFPIA are from Europe<br />
FDA and PhRMA are from USA<br />
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</div><div class="MsoNormal"><b><i>Non Voting Members of ICH-</i></b></div><div class="MsoNormal"><b><i><br />
</i></b></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjfcVbUzYDLXzQbotjXUwrcCroZEtQ_ZDF5mzz5gkqE4REp53uNwtpt2T3df9e0HQEut-H2JqVeTWVDlbEDxDj-u2DWm5Optp2Fjw5cXrdXkCBmMVPUbmSlZLex2tjjDSv1p36_GCRGtJym/s1600/non+voting+members.bmp" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="281" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjfcVbUzYDLXzQbotjXUwrcCroZEtQ_ZDF5mzz5gkqE4REp53uNwtpt2T3df9e0HQEut-H2JqVeTWVDlbEDxDj-u2DWm5Optp2Fjw5cXrdXkCBmMVPUbmSlZLex2tjjDSv1p36_GCRGtJym/s640/non+voting+members.bmp" width="640" /></a></div><br />
<div class="MsoNormal"><b>WHO</b>-World Health Organization</div><div class="MsoNormal"><b>EFTA</b>-European Free Trade Association</div><div class="MsoNormal"><b>IFPMA</b>- International Federation of Pharmaceutical Manufacturers & Associations</div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><b><i>Organisation of ICH</i></b></div><div class="MsoNormal"><b><i><br />
</i></b></div><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody>
<tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgG2fMBBpqRVLb_Qsrwc0SbYPu1CsQ6YWPa7PLEO-yUGcIIyTWN_zqqRjpDDSVNufQhOb0bC5idI56YsYe7tQXluV-R0HA8z7jNt-tFYU9wYhsa37x2BHfqse7chXh4ukbdRBZ6kWhBRMrK/s1600/final.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="361" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgG2fMBBpqRVLb_Qsrwc0SbYPu1CsQ6YWPa7PLEO-yUGcIIyTWN_zqqRjpDDSVNufQhOb0bC5idI56YsYe7tQXluV-R0HA8z7jNt-tFYU9wYhsa37x2BHfqse7chXh4ukbdRBZ6kWhBRMrK/s640/final.bmp" width="640" /></a></td></tr>
<tr><td class="tr-caption" style="text-align: center;">Source: ich.org</td></tr>
</tbody></table><div class="MsoNormal"><br />
<div class="MsoNormal"><b><br />
</b></div><br />
<b><i>Process of Harmonisation:</i></b></div><div class="MsoNormal"><b><i><br />
</i></b></div><div class="MsoNormal"></div><div class="MsoNormal"><span class="Apple-style-span" style="font-family: inherit;">ICH harmonisation activities fall into 4 categories: Formal ICH Procedure, Q&A Procedure, Revision Procedure and Maintenance Procedure, depending on the activity to be undertaken (see below).</span></div><div class="MsoNormal"><span class="Apple-style-span" style="font-family: inherit;"><br />
</span></div><div class="separator" style="clear: both; text-align: center;"></div><div class="MsoNormal"><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgtciKqTpWcsiTPVJa9p5dFiEEYoDKjPaOyoWdign_jGyNhHJjLancAcyEONkTWpy5ELXUDnwo0ju47HvyE5aQejmWsD32CeywPeBYfBHv3ga7ojWzGRyib1mVaa0hfuU_cha95H0DMQYJ3/s1600/process+of+harmonisation.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="480" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgtciKqTpWcsiTPVJa9p5dFiEEYoDKjPaOyoWdign_jGyNhHJjLancAcyEONkTWpy5ELXUDnwo0ju47HvyE5aQejmWsD32CeywPeBYfBHv3ga7ojWzGRyib1mVaa0hfuU_cha95H0DMQYJ3/s640/process+of+harmonisation.jpg" width="640" /></a></div></div><div class="MsoNormal"><span class="Apple-style-span" style="font-family: inherit;"><b><i>Formal ICH Procedure for new topic of harmonisation :</i></b></span></div><div class="MsoNormal"><span class="Apple-style-span" style="font-family: inherit;"><b><i><br />
</i></b></span></div><div class="MsoNormal"><span class="Apple-style-span" style="font-family: inherit;"></span></div><div class="MsoNormal"><span class="Apple-style-span" style="font-family: inherit;">The Formal ICH Procedure is a step-wise procedure consisting of 5 steps .This procedure is followed for the harmonisation of all new ICH topics</span></div><div class="MsoNormal"><span class="Apple-style-span" style="font-family: inherit;"><br />
</span></div><div class="separator" style="clear: both; text-align: center;"><span class="Apple-style-span" style="font-family: inherit;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiKvMiKemvapKrFqKlsJMzOHrhDlpN1Dv6_672bZUrTp5ePDZ5sGVjULoZX3s6Vdxh8sqRHF_VSw1n199BxhS0VfSXYS4dzmyTbhJNNH0MP7wIqDUSAwizZnKTmv4VEw0duwx5lG9VzWtrR/s1600/harmonisation+procedure.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="480" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiKvMiKemvapKrFqKlsJMzOHrhDlpN1Dv6_672bZUrTp5ePDZ5sGVjULoZX3s6Vdxh8sqRHF_VSw1n199BxhS0VfSXYS4dzmyTbhJNNH0MP7wIqDUSAwizZnKTmv4VEw0duwx5lG9VzWtrR/s640/harmonisation+procedure.jpg" width="640" /></a></span></div><div class="MsoNormal"><span class="Apple-style-span" style="font-family: inherit;"><br />
</span></div><br />
<div class="MsoNormal">ICH guidelines have been adopted as law in several countries, but are only used as guidance for the U.S. Food and Drug Administration</div><div class="MsoNormal"><br />
</div><div class="MsoNormal">Finally, I would like to end with a beautiful quote by Henry ford "<b><i>Coming together is a beginning. Keeping together is progress. Working together is success</i></b>"</div><div class="MsoNormal"><br />
</div><div class="MsoNormal"><br />
<div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="color: black; font-family: 'Times New Roman', serif;"><b>P.S.</b> <span class="Apple-style-span" style="font-size: medium;"><o:p></o:p></span></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">1. Explanation of Abbreviations quoted in the above post-<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt; text-align: justify; text-justify: inter-ideograph;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">(i)<b>MedDRA or Medical Dictionary for Regulatory Activities</b> is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">(ii)<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">Q-Quality<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">S-Safety<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">E-Efficacy<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">M-Multidisciplinary<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">(iii)Q3C is - Impurities :Guideline for Residual Solvents<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">(iv) M2 is -Multi-disciplinary Group 2<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">2. In my next posts, I will be mainly focusing on the important ICH guidelines.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt;"><div style="text-align: justify;"><b><span style="color: black; font-family: 'Times New Roman', serif;">Keywords :</span></b><span style="color: black; font-family: 'Times New Roman', serif; font-size: 13.5pt;"> </span><span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px;">ICH, MHLW , JPMA ,EU , EFPIA , FDA, PhRMA, WHO, EFTA, IFPMA.</span></div></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 6.0pt; tab-stops: 176.25pt;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div></div>References :<br />
1.<a href="http://www.ich.org/">http://www.ich.org/</a><br />
2.<a href="http://www.wikipedia.org/">http://www.wikipedia.org/</a><br />
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<br />
</div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com5tag:blogger.com,1999:blog-7538891640847716324.post-25140665913125071582011-10-14T18:24:00.002+05:302012-03-19T13:31:06.785+05:30Drug Master Files (DMFs)<div dir="ltr" style="text-align: left;" trbidi="on"><br />
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">What is a Drug Master File (DMF) ?</span></i></b><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">Important facts regarding DMFs</span></i></b><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div><ul type="disc"><li class="MsoNormal" style="color: black; line-height: normal; mso-list: l6 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">It is submitted to FDA to provide confidential information<o:p></o:p></span></li>
<li class="MsoNormal" style="color: black; line-height: normal; mso-list: l6 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">Its submission is not required by law or regulations<o:p></o:p></span></li>
<li class="MsoNormal" style="color: black; line-height: normal; mso-list: l6 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">It is neither approved nor disapproved<o:p></o:p></span></li>
<li class="MsoNormal" style="color: black; line-height: normal; mso-list: l6 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><div class="MsoNormal"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application.<o:p></o:p></span></div></span></li>
<li class="MsoNormal" style="color: black; line-height: normal; mso-list: l6 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these<o:p></o:p></span></li>
<li class="MsoNormal" style="color: black; line-height: normal; mso-list: l6 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420<o:p></o:p></span></li>
<li class="MsoNormal" style="color: black; line-height: normal; mso-list: l6 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">It is not required when applicant references its own information<o:p></o:p></span></li>
</ul><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;">Types of Drug Master Files-</span></i></b><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Type I:</span></i></b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> </span></i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)<b><o:p></o:p></b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Type II: </span></i></b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product<b><o:p></o:p></b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Type III: </span></i></b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Packaging Material<b><o:p></o:p></b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Type IV :</span></i></b><b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> </span></b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation<b><o:p></o:p></b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Type V:</span></i></b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> FDA Accepted Reference Information (FDA discourages its use)<b><o:p></o:p></b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Each DMF submission should contain -<o:p></o:p></span></b></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"><br />
</span></b></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">1.Transmittal letter<o:p></o:p></span></b></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">2.Administrative information<o:p></o:p></span></b></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">1.Transmittal letter<o:p></o:p></span></b></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">For original submissions, transmittal letter should include-<b><o:p></o:p></b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> a.Identification of submission<b><o:p></o:p></b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> b.Identification of the applications<b><o:p></o:p></b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> c.Signature of the holder or the authorized representative.<b><o:p></o:p></b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 3; text-align: justify; text-justify: inter-ideograph;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> d.Typewritten name and title of the signer</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">For amendments, transmittal letter should include-<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">a Identification of submission<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">b A description of the purpose of submission<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">c Signature of the holder or the authorized representative<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">d Typewritten name and title of the signer<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><span class="Apple-style-span" style="color: #484138; font-family: 'Times New Roman', serif;"><br />
</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><b>2.Administrative information</b><o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">For original submissions, administrative information should include-<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">a. Names and addresses of the following:<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">(i) DMF holder.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">(ii) Corporate headquarters.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">(iii) Manufacturing/processing facility.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">(iv) Contact for FDA correspondence.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">(v) Agent(s), if any.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">b. The specific responsibilities of each person listed in any of the categories in Section a.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">c. Statement of commitment.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">A signed statement by the holder certifying that the DMF is current and that the DMF holder will comply with the statements made in it. <o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">For amendments, administrative information should include-<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">a. Name of DMF holder.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">b. DMF number.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">c. Name and address for correspondence.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">d. Affected section and/or page numbers of the DMF.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">e. The name and address of each person whose IND, NDA, ANDA, DMF, or Export Application relies on the subject of the amendment for support.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">f. The number of each IND, NDA, ANDA, DMF, and Export Application that relies on the subject of the amendment for support, if known.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">g. Particular items within the IND, NDA, ANDA, DMF, and Export Application that are affected, if known.<o:p></o:p></span></div><div class="MsoNormal" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">Format, Assembly, and Delivery of DMF-</span></i></b></div><div class="MsoListParagraphCxSpFirst" style="mso-list: l0 level1 lfo11; text-indent: -.25in;"></div><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">The DMF must be in the English language. Whenever a submission contains information in another language, an accurate certified English translation must also be included.</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">Each page of each copy of the DMF should be dated and consecutively numbered. An updated table of contents should be included with each submission.</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">An original and duplicate are to be submitted for all DMF submissions.</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: Symbol; font-size: 12pt; line-height: 115%;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">Each volume of a DMF should, in general, be no more than 2 inches thick. For multivolume submissions, number each volume. For example, for a 3 volume submission, the volumes would be numbered 1 of 3, 2 of 3, and 3 of 3.</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">Drug Master File holders and their agents/representatives should retain a complete reference copy that is identical to, and maintained in the same chronological order as, their submissions to FDA.</span></li>
</ul><ul style="text-align: left;"><li><span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px; line-height: 18px;">U.S. standard paper size (8-1/2 by 11 inches) is preferred.</span></li>
</ul><div><span style="font-family: Symbol; font-size: 12pt; line-height: 115%;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"><br />
</span></span></div><div><span style="font-family: Symbol; font-size: 12pt; line-height: 115%;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">Drug Master File submissions and correspondence should be addressed as follows:</span><br />
<div class="MsoNormal" style="line-height: 15.75pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> Drug Master File Staff<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 15.75pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> Food and Drug Administration<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 15.75pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> 5901-B Ammendale Rd.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 15.75pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"> Beltsville, MD 20705-1266<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><span class="Apple-style-span" style="color: #484138; font-family: 'Times New Roman', serif;"><br />
</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">AUTHORIZATION TO REFER TO A DRUG MASTER FILE<o:p></o:p></span></i></b></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">Before FDA can review DMF information in support of an application, the DMF holder must submit in duplicate to the DMF a letter of authorization permitting FDA to reference the DMF<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">The letter of authorization (LOA) should include the following:<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">The date.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">Name of DMF holder.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">DMF number.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">Name of person(s) authorized to incorporate information in the DMF by reference.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">Specific product(s) covered by the DMF.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">Submission date(s) of 5, above.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">Section numbers and/or page numbers to be referenced.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">Statement of commitment that the DMF is current and that the DMF holder will comply with the statements made in it.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">Signature of authorizing official.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">Typed name and title of official authorizing reference to the DMF.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">The holder of DMF should send a copy of LOA to affected applicant, sponsor or other holder who is authorized to incorporate information contained in the DMF. The copy of LOA issued by DMF holder should be included in the application by applicant, sponsor or holder referencing the DMF.<o:p></o:p></span></div><div class="MsoListParagraph" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 3; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Format and Content of DMF</span></i></b><b><span style="background-attachment: initial; background-clip: initial; background-color: #b2b1a4; background-image: initial; background-origin: initial; color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></b></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 3; text-align: justify; text-justify: inter-ideograph;"><span class="Apple-style-span" style="color: #484138; font-family: 'Times New Roman', serif;"><b><br />
</b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">DMFs may be submitted following the format recommended in the "<a href="http://www.fda.gov/RegulatoryInformation/Guidances/ucm129901.htm"><span style="color: blue;">Guidance for Industry M4Q: The CTD - Quality</span></a>".<b><span style="background-attachment: initial; background-clip: initial; background-color: #b2b1a4; background-image: initial; background-origin: initial;"><o:p></o:p></span></b></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 3; text-align: justify; text-justify: inter-ideograph;"><span class="Apple-style-span" style="color: #484138; font-family: 'Times New Roman', serif;"><b><br />
</b></span></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">Incomplete submission<o:p></o:p></span></i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"><br />
</span></i></b></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">If the submission is administratively incomplete or inadequate, it will be returned to the submitter with a letter of explanation from the Drug Master File Staff, and it will not be assigned a DMF number.<o:p></o:p></span></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"><br />
</span></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">DMF review</span></i></b></div><div class="MsoListParagraph" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-add-space: auto; mso-list: l7 level1 lfo2; tab-stops: list .5in; text-indent: -.25in;"></div><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: Symbol; font-size: 10pt;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">An original DMF submission will be examined on receipt to determine whether it meets minimum requirements for format and content. If the submission is administratively acceptable, FDA will acknowledge its receipt and assign it a DMF number.</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p> </o:p></span><span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px;">The agency will review information in a DMF only when an IND sponsor, an applicant for an NDA, ANDA, or Export Application, or another DMF holder incorporates material in the DMF by reference. </span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span class="Apple-style-span" style="line-height: 16px;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"> </span><span class="Apple-style-span" style="line-height: normal;"><span style="font-family: Symbol; font-size: 10pt;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">If FDA reviewers find deficiencies in the information provided in a DMF, a letter describing the deficiencies is sent to the DMF holder and also the person who relies on the information in the deficient DMF (However, only general subject of deficiency is revealed to the applicant/person referring information in DMF)</span></span></span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px;">When the holder submits the requested information to the DMF in response to the agency's deficiency letter, the holder should also send a copy of the accompanying transmittal letter to the affected persons relying on the DMF and to the FDA reviewing division that identified the deficiencies. The transmittal letter will provide notice that the deficiencies have been addressed.</span></li>
</ul><div class="MsoListParagraphCxSpMiddle" style="text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">Holder Obligations<o:p></o:p></span></i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"><br />
</span></i></b></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">Any change or addition, including a change in authorization related to specific customers, should be submitted in duplicate and adequately cross referenced to previous submission(s). The reference should include the date(s), volume(s), section(s), and/or page number(s) affected.<o:p></o:p></span></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"><br />
</span></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">Notice Required for Changes to a Drug Master File<o:p></o:p></span></i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"><br />
</span></i></b></div><div class="MsoNormal" style="line-height: 12.75pt; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">A holder must notify each affected applicant or sponsor who has referenced its DMF of any pertinent change in the DMF . Notice should be provided well before making the change in order to permit the sponsor/applicant to supplement or amend any affected application(s) as needed.</span><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div><div class="MsoNormal" style="line-height: 12.75pt; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: 12.75pt; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Listing of Persons Authorized To Refer to a Drug Master File</span></i></b><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div><ul type="disc"><li class="MsoNormal" style="color: black; line-height: 12.75pt; mso-list: l2 level1 lfo3; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">A DMF is required to contain a complete list of persons authorized to incorporate information in the DMF by reference. The holder should update the list in the annual report.</span><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></li>
</ul><ul type="disc"><li class="MsoNormal" style="color: black; line-height: normal; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">The updated list should contain the holder's name, DMF number, and the date of the update.</span><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></li>
</ul><ul type="disc"><li class="MsoNormal" style="color: black; line-height: normal; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">The update should identify by name (or code) the information that each person is authorized to incorporate and give the location of that information by date, volume, and page number.</span><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></li>
</ul><ul style="margin-top: 0in;" type="disc"><li class="MsoNormal" style="color: black; line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Any person whose authorization has been withdrawn during the previous year should be identified under a suitable caption.</span><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></li>
</ul><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; margin-left: 0.5in; margin-right: 0in; margin-top: 0in; text-align: justify;"><br />
</div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"> Annual Report<o:p></o:p></span></i></b></div><div class="MsoListParagraphCxSpFirst" style="mso-list: l10 level1 lfo10; text-indent: -.25in;"></div><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: Symbol; font-size: 12pt; line-height: 115%;"><span style="font-family: 'Times New Roman'; font-size: 7pt; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">The holder should provide an annual report on the anniversary date of the original submission. This report should contain complete list of authorized persons persons referring the DMF and should also identify all changes and additional information incorporated into the DMF since the previous annual report on the subject matter of the DMF. If the subject matter of the DMF is unchanged, the DMF holder should provide a statement that the subject matter of the DMF is current.</span></li>
</ul><ul style="text-align: left;"><li style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"><o:p> </o:p></span><span class="Apple-style-span" style="font-family: 'Times New Roman', serif; font-size: 16px; line-height: 18px;">Failure to update or to assure FDA annually that previously submitted material and lists in the DMF remain current can cause delays in FDA review of a pending IND, NDA, ANDA, Export Application, or any amendment or supplement to such application; and FDA can initiate procedures for closure of the DMF.</span></li>
</ul><br />
<div class="MsoListParagraphCxSpLast" style="text-align: justify; text-indent: -0.25in;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"><br />
</span></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"> Appointment of an Agent<o:p></o:p></span></i></b></div><div class="MsoNormal" style="text-align: justify;"><b><i><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;"><br />
</span></i></b></div><div class="MsoNormal" style="text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt; line-height: 115%;">Domestic DMF holders do not need to appoint an agent or representative, although foreign DMF holders are encouraged to engage a U.S. agent.When an agent is appointed, the holder should submit a signed letter of appointment to the DMF giving the agent's name, address, and scope of responsibility (administrative and/or scientific). <o:p></o:p></span></div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Transfer of Ownership</span></i></b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">To transfer ownership of a DMF to another party, the holder should so notify FDA and authorized persons in writing. The letter should include the following:<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Name of transferee<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Address of transferee<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Name of responsible official of transferee<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Effective date of transfer<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Signature of the transferring official<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">Typewritten name and title of the transferring official.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: 13.5pt; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">The new holder should submit a letter of acceptance of the transfer and an update of the information contained in the DMF, where appropriate. Any change relating to the new ownership (e.g., plant location and methods) should be included.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: 12.75pt; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: 12.75pt; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">MAJOR REORGANIZATION OF A DRUG MASTER FILE</span></i></b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div><div class="MsoNormal" style="line-height: 12.75pt; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: 12.75pt; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">A holder who plans a major reorganization of a DMF is encouraged to submit a detailed plan of the proposed changes and request its review by the Drug Master File Staff. The staff should be given sufficient time to comment and provide suggestions before a major reorganization is undertaken.<o:p></o:p></span></div><div class="MsoNormal" style="line-height: 12.75pt; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><br />
</div><div class="MsoNormal" style="line-height: 12.75pt; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><b><i><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;">CLOSURE OF A DRUG MASTER FILE</span></i></b><span style="color: #484138; font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div><ul type="disc"><li class="MsoNormal" style="color: #484138; line-height: normal; mso-list: l8 level1 lfo7; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">A holder who wishes to close a DMF should submit a request to the Drug Master File Staff stating the reason for the closure. <o:p></o:p></span></li>
</ul><ul type="disc"><li class="MsoNormal" style="color: #484138; line-height: normal; mso-list: l4 level1 lfo8; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">The request should include a statement that the holder's obligations have been fulfilled.<o:p></o:p></span></li>
</ul><ul type="disc"><li class="MsoNormal" style="color: #484138; line-height: normal; mso-list: l5 level1 lfo9; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in; text-align: justify; text-justify: inter-ideograph;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;">The Agency may close a DMF that does not contain an annual update of persons authorized to incorporate information in the DMF by reference and a list of changes made since the previous annual report. The holder will be notified of FDA's intent to close the DMF.</span></li>
</ul><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: justify; text-justify: inter-ideograph;"><br />
<i style="font-weight: bold;">Keywords- </i>FDA, DMF, Types of DMF , CTD., LOA.<br />
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</div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><i><b>References from FDA's Website-</b></i><o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><br />
</div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;"><a href="http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm073164.htm#.TpPpb6ATd6k.blogger"><span style="color: blue;">Drug Master Files (DMFs) Guideline for Drug Master Files (DMF)</span></a></span><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: 0.0001pt; text-align: justify;"><span style="color: black; font-family: 'Times New Roman', serif; font-size: 12pt;"><a href="http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm#.TpRYyQZx23s.blogger"><span style="color: blue;">Drug Master Files (DMFs)</span></a></span><span style="font-family: 'Times New Roman', serif; font-size: 12pt;"><o:p></o:p></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; mso-outline-level: 4; text-align: justify; text-justify: inter-ideograph;"><span class="Apple-style-span" style="color: #484138; font-family: 'Times New Roman', serif;"><b><br />
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</div></div></div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com2tag:blogger.com,1999:blog-7538891640847716324.post-20791987953033173802011-10-12T21:02:00.001+05:302012-05-13T17:17:22.738+05:30Drug discovery and development process<div dir="ltr" style="text-align: left;" trbidi="on">
<br />
<a href="http://www.youtube.com/watch?v=3Gl0gAcW8rw"><span style="color: blue;">Youtube Link to an interesting video on Drug Discovery and Developmental Process released by Novartis.</span></a><br />
<br />
Note : Click on the above link to watch the video.</div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com2tag:blogger.com,1999:blog-7538891640847716324.post-67296327045145264972011-10-10T10:46:00.000+05:302014-03-31T19:54:32.675+05:30Universities offering Masters courses in Regulatory Affairs in USA<div dir="ltr" style="text-align: left;" trbidi="on">
Here are the Universities in USA offering Master of Science (MS) in Pharmaceutical Regulatory Affairs and allied subjects -<br />
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<b>1.Purdue University, College of Pharmacy, West Lafayette-IN</b><br />
Master of Science in Regulatory Quality Compliance<br />
Website Link-<a href="http://www.ipph.purdue.edu/graduateprogram/ms-rqc/admissions.php"><b><span style="color: blue;">http://www.ipph.purdue.edu/graduateprogram/ms-rqc/admissions.php</span></b></a><br />
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<b><b>2.University of Southern California, School of Pharmacy, Los Angeles-CA</b></b></div>
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Master of Science in Regulatory science </div>
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Website Link-<a href="http://regulatory.usc.edu/Masters.htm"><b><span style="color: blue;">http://regulatory.usc.edu/Masters.htm</span></b></a><br />
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<b><b>3.North Eastern University, College of Professional studies, Boston-MA</b></b></div>
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Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices </div>
<div>
Website Link-<a href="http://cps.neu.edu/degree-programs/graduate/masters-degrees/masters-regulatory-affairs.php" style="font-weight: bold;"><span style="color: blue;">http://cps.neu.edu/degree-programs/graduate/masters-degrees/masters-regulatory-affairs.php</span></a></div>
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<b><b>4.Massachusetts College of Pharmacy and Health Sciences, Boston-MA</b></b></div>
<span class="Apple-style-span" style="color: #291b09; font-weight: 800; line-height: 10px;"> </span><span class="Apple-style-span" style="color: black; line-height: normal;">Master of Science</span><span class="Apple-style-span" style="color: #291b09; line-height: normal;"><span class="Apple-style-span" style="line-height: 10px;"> In Regulatory Affairs and Health Policy</span></span></div>
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<span class="Apple-style-span" style="line-height: normal;"><span class="Apple-style-span" style="color: #291b09;"><span class="Apple-style-span" style="line-height: 10px;">Website Link-</span></span><a href="http://www.mcphs.edu/academics/programs/regulatory-affairs-and-health-policy"><b><span style="color: blue;">http://www.mcphs.edu/academics/programs/regulatory-affairs-and-health-policy</span></b></a></span></div>
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<b>5.Temple University, School of Pharmacy, Philadelphia-PA</b></div>
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Master of Science in QA/RA </div>
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Website Link-<a href="http://www.temple.edu/pharmacy_qara/applying.htm#MS_in_Quality_Assurance2"><b><span style="color: blue;">http://www.temple.edu/pharmacy_qara/applying.htm#MS_in_Quality_Assurance2</span></b></a></div>
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<b>6.Arizona State University,College of Nursing and Health Innovation, Phoenix-AZ</b><br />
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Master of Science in Regulatory Science & Health Safety<br />
Course developed in collaboration with USFDA</div>
Website Link-<a href="http://nursingandhealth.asu.edu/regulatory"><b><span style="color: blue;">http://nursingandhealth.asu.edu/regulatory</span></b></a><br />
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<b>7.St. John's University,</b></div>
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<b>College of Pharmacy and Allied Health Professions, Queens-NY</b></div>
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Master of Science in Pharmacy Administration (Specialization in Regulatory Affairs/Quality Assurance)</div>
Website Link-<a href="http://www.stjohns.edu/academics/graduate/pharmacy/departments/pas/ms" style="font-weight: bold;"><span style="color: blue;">http://www.stjohns.edu/academics/graduate/pharmacy/departments/pas/ms</span></a><br />
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<b>8.Long Island University,</b><br />
<b>Arnold & Marie Schwartz college of Pharmacy and Health Sciences, Brooklyn-NY</b><br />
Master of Science in Drug Regulatory Affairs<br />
Website Link-<a href="http://www2.brooklyn.liu.edu/pharmacy/div_social_admin_sciences_drug_reg.html"><b><span style="color: blue;">http://www2.brooklyn.liu.edu/pharmacy/div_social_admin_sciences_drug_reg.html</span></b></a><br />
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<b>9. John Hopkins University, Centre for Biotechnology Education, Baltimore-MD.</b><span class="Apple-style-span" style="background-color: white;"></span><br />
Master of Science in Bioscience Regulatory Affairs (Mainly deals with Biotechnology Regulatory Affairs)<br />
Website Link-<a href="http://biotechnology.jhu.edu/graduate-education/ms-in-bsra/index.html"><b><span style="color: blue;">http://biotechnology.jhu.edu/graduate-education/ms-in-bsra/index.html</span></b></a><br />
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<b>10. Regis college, Weston-MA</b></div>
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Master of Science<span class="Apple-style-span" style="color: #291b09;"><span class="Apple-style-span" style="line-height: 10px;"> in Regulatory and Clinical Research Management </span></span></div>
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<span class="Apple-style-span" style="line-height: 10px;"><span style="color: #291b09;">Website Link</span><span style="color: blue;">-</span></span><a href="http://www.regiscollege.edu/graduate_programs/department.cfm?id=Health_Product_Reg"><b><span style="color: blue;">http://www.regiscollege.edu/graduate_programs/department.cfm?id=Health_Product_Reg</span></b></a></div>
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<b>11.The University of Georgia, Gwinnett Campus, Lawrenceville-GA*</b><br />
Master of Science for Regulatory Affairs<br />
Website Link<span style="color: blue;">-<a href="http://ra.rx.uga.edu/"><b>http://ra.rx.uga.edu/</b></a></span><br />
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<b>12.San Diego State University, Centre for Distance Learning*</b><br />
Master of Science in Regulatory Affairs<br />
Website Link-<a href="http://interwork.sdsu.edu/cbbd/regaffairs/ms_regaffairs.htm"><b><span style="background-color: white; color: blue;">http://interwork.sdsu.edu/cbbd/regaffairs/ms_regaffairs.htm</span></b></a><br />
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<b>13. North Western University, School of Continuing Education, Chicago-IL*</b><br />
Master of Science in Quality Assurance and Regulatory Science<br />
Website Link-<a href="http://www.scs.northwestern.edu/grad/mqars/"><b><span style="color: blue;">http://www.scs.northwestern.edu/grad/mqars/</span></b></a><br />
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<b><span style="font-family: inherit;">14.University of Florida, Gainesville-FL*</span></b><br />
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Master of Science in Pharmacy-Drug Regulatory Affairs</div>
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Website Lin<span style="background-color: white;">k<span style="color: blue;">-</span></span><b><a href="http://www.distance.ufl.edu/program.aspx?p="><span style="color: blue;">http://www.distance.ufl.edu/program.aspx?p=</span></a><span style="background-color: white;"><span style="color: blue;"><a href="http://www.distance.ufl.edu/program.aspx?p=%C2%A0"> </a> </span> <span style="color: red;"> </span></span><span style="color: red;"> </span></b> </div>
<b style="font-family: inherit;">15. <span style="background-color: white; color: #222222;">Tufts University, School of Medicine</span></b><br />
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Master of Science in Development and Regulation of Medicines
and Devices</div>
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Website Link -<span style="color: blue;">
<a href="http://publichealth.tufts.edu/Academics/MS-DRMD"><b><span style="color: blue;">http://publichealth.tufts.edu/Academics/MS-DRMD</span></b></a></span></div>
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Other Related Course-<br />
<b>University of Florida, College of Pharmacy, Gainsville-FL</b><br />
Master of Science in Pharmaceutical outcomes and Policy<br />
Course is offered in collaboration with FDA Center for Drug evaluation and research.<br />
The students enrolled for the course will have a guaranteed intership at the FDA or Industry.<br />
Eligibility-Terminal Degree in Health Sciences such as PharmD<br />
Website Link-<a href="http://www.cop.ufl.edu/pop/education/residential-masters/"><b><span style="color: blue;">http://www.cop.ufl.edu/pop/education/residential-masters/</span></b></a><br />
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<b>My preferred University</b>-<br />
If I were to go for MS in RA, Arizona State University would be my most preferred one for the following reasons-<br />
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1.The course is developed in collaboration with USFDA (the most respected Regulatory agency in the world) and the students will receive guest lectures from FDA personnel.<br />
2. Chance for internship with FDA's CDER.<br />
3.The fees and cost living will be much less than most of the above universities.<br />
4.The competition for admission will be probably less as the university is not much famous.<br />
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References-<br />
1<b style="color: #073763;">.</b><a href="http://www.raps.org/your-career/resource-tools/degree-and-certificate-programs.aspx#us"><span style="color: blue;"><b>http://www.raps.org/your-career/resource-tools/degree-and-certificate-programs.aspx#us</b></span></a><br />
2.<a href="http://grad-schools.usnews.rankingsandreviews.com/best-graduate-schools/top-pharmacy-schools/pharmacy-rankings"><b><span style="color: blue;">http://grad-schools.usnews.rankingsandreviews.com/best-graduate-schools/top-pharmacy- schools/pharmacy-rankings</span></b></a><br />
3<span style="color: blue;">.<a href="http://en.wikipedia.org/"><span style="color: blue;"><b>http://en.wikipedia.org/</b></span></a></span><br />
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<b>Note- </b><br />
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1.Most of the Universities offer the courses through various modes such as Full time, Part time, online modes or combination of these modes. Hence the prospective students are advised to check with the university representatives whether the universities offer the courses in their mode of interest before applying.</div>
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2. The universities offering MS only through part time/online modes are indicated with "*" ..</div>
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Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com95tag:blogger.com,1999:blog-7538891640847716324.post-19034042677203729712011-10-04T00:45:00.004+05:302012-07-13T14:41:54.816+05:30Institutes offering Regulatory Affairs Courses in India<div dir="ltr" style="text-align: left;" trbidi="on">
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The colleges/ institutes offering Masters and Diploma courses in Pharmaceutical Regulatory Affairs in India -</div>
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Masters Courses in Regulatory Affairs-</div>
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<b>1.Birla Institute of Technology, Mesra, Ranchi</b></div>
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Approved by PCI and AICTE</div>
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M. Pharmacy (Quality Assurance and Regulatory Affairs )</div>
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Website link-<a href="http://www.bitmesra.ac.in/cms.aspx?this=1&mid=34">http://www.bitmesra.ac.in/cms.aspx?this=1&mid=34</a></div>
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<b>2. JSS college of Pharmacy-Mysore</b></div>
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Approved by PCI and AICTE</div>
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M. Pharmacy (Pharmaceutical Regulatory Affairs )</div>
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Website link-<a href="http://www.jsspharma.org/default.aspx">http://www.jsspharma.org/default.aspx</a></div>
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<b>3. JSS college of Pharmacy-Ooty</b></div>
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Approved by PCI and AICTE</div>
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M. Pharmacy (Pharmaceutical Regulatory Affairs )</div>
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Website link-<a href="http://www.jsscpooty.org/">http://www.jsscpooty.org/</a></div>
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<b>4.Manipal University (Deemed University), Manipal, Karnataka*</b></div>
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Department of Advanced Pharmaceutical Sciences,</div>
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<span class="Apple-style-span" style="color: #4b443d;">MSc Pharmaceutical Regulatory Affairs,</span></div>
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<span class="Apple-style-span" style="color: #4b443d;">WebsiteLink-</span><a href="http://www.manipal.edu/PROSPECTIVESTUDENTS/DECIDINGWHATTOSTUDY/Pages/PostGraduate.aspx">http://www.manipal.edu/PROSPECTIVESTUDENTS/DECIDINGWHATTOSTUDY/Pages/PostGraduate.aspx</a></div>
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<b>5.Lachoo Memorial College of Science and Technology (Pharmacy), Jodhpur</b></div>
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M. Pharm. (Pharmaceutical Management and Regulatory Affairs)</div>
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Approved by PCI and AICTE</div>
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Website Link-<a href="http://www.lachoomemorial.org/sss.php?indexid=2">http://www.lachoomemorial.org/sss.php?indexid=2</a></div>
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<b>6.Maharshi Dayanand University, Rohtak-Haryana</b></div>
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Department of Pharmaceutical Sciences</div>
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M.Pharma (Drug regulatory Affairs)</div>
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Approved by UGC and PCI</div>
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Website link-<a href="http://www.mdurohtak.ac.in/info/acad_fac_perfvisart_pharmaceuticalscience.html">http://www.mdurohtak.ac.in/info/acad_fac_perfvisart_pharmaceuticalscience.html</a></div>
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<b>7. Alliance Institute of Advanced Pharmaceutical and Health sciences, Hyderabad*</b></div>
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<span class="Apple-style-span" style="color: #333333;"><span class="Apple-style-span" style="line-height: 18px;">Affiliated to JNTUH,</span></span></div>
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<span class="Apple-style-span" style="color: #333333;"><span class="Apple-style-span" style="line-height: 18px;">MS Drug Development and Regulatory Affairs</span></span></div>
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Website link-<a href="http://www.allianceinstitute.org/index.php">http://www.allianceinstitute.org/index.php</a></div>
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<b>8. Brown's College of Pharmacy, Khammam, Andhra Pradesh</b></div>
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Affiliated to Kakatiya University & Approved by PCI.</div>
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<b><span class="Apple-style-span" style="font-weight: normal;">M. Pharmacy (Drug Regulatory Affairs )</span></b> </div>
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<b>9. Sree Dattha Institute of Pharmacy, Ibrahimpatnam , R.R District. Andhra Pradesh</b></div>
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Approved by PCI and AICTE<b> </b></div>
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<b><span class="Apple-style-span" style="font-weight: normal;">M. Pharmacy ( Pharmaceutical Management and Regulatory Affairs )</span></b></div>
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<b><span class="Apple-style-span" style="font-weight: normal;">Website link-</span></b><a href="http://www.sreedattha.ac.in/">http://www.sreedattha.ac.in/</a></div>
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Institute offering Diploma Courses in Regulatory Affairs-</div>
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<b>1.Jamia Hamdard University, New Delhi</b></div>
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Deemed University, Accredited by NAAC in 'A' grade</div>
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PG Diploma in Pharmaceutical Regulatory Affairs</div>
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<b><span class="Apple-style-span" style="font-weight: normal;">Website link-</span></b><a href="http://www.jamiahamdard.edu/ug.asp">http://www.jamiahamdard.edu/ug.asp</a></div>
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<b>2. <span class="Apple-style-span" style="color: #494848; line-height: 22px;"><span class="Apple-style-span" style="font-family: inherit;">Bioinformatics Institute of India (BII), Noida*</span></span></b></div>
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<span class="Apple-style-span" style="color: #494848; font-family: inherit;"><span class="Apple-style-span" style="line-height: 22px;">Industry Program in Pharma Regulatory Affairs</span></span></div>
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<span class="Apple-style-span">Website link<b>-</b></span><a href="http://www.bii.in/programs/distanceLearning/industryprogram1.html#">http://www.bii.in/programs/distanceLearning/industryprogram1.html#</a></div>
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<b>3. Institute of Pharmaceutical Education and Research (IPER), Pune*</b></div>
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Diploma in Drug Regulatory Affairs</div>
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<span class="Apple-style-span">Website link<b>-</b></span></div>
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<a href="http://www.pharmadiplomas.com/index.php?option=com_content&view=article&id=57&Itemid=2" style="text-align: justify;">http://www.pharmadiplomas.com/index.php?option=com_content&view=article&id=57&Itemid=2</a><br />
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<b>4.Global Institute of Regulatory Affairs (GIRA), Pune *</b><br />
Advanced PG Diploma in Regulatory Affairs (Full Time)<br />
PG Diploma in Regulatory Affairs (Part Time)<br />
Website Link-<a href="http://www.regulatoryinstitute.com/index.html" style="background-color: white;">http://www.regulatoryinstitute.com/index.html</a></div>
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<b>Note- </b></div>
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1.The colleges/institutes with "*" mark are not recognised by any Government Councils, but I listed them because they are well recognised by Pharma companies for their courses.</div>
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2. I listed the Institutes in the decreasing order of my personal preferences based on the credibility of institutes/colleges, year of establishment, popularity etc.</div>
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3.Apart from the above colleges , I came across several other institutes/colleges offering courses in Pharmaceutical Regulatory Affairs but I didn't list them because I seriously doubt their authenticity and credibility.</div>
</div>Rajesh Yelugoilahttp://www.blogger.com/profile/18307532821496397339noreply@blogger.com280