Sunday, 3 March 2013


History and background of GDUFA:
  • The one hundred twelfth congress of the United States of America at the second session on 3rd 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.
  •  This act may be cited as the “Food and Drug Administration Safety and Innovation Act”.
  •  The amendment is referred to as Generic Drug User Fee Amendments of 2012 (GDUFA).
  •  On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law. 
  •  On Oct. 1, 2012, FDA implemented the Generic Drug User Fee Amendments of 2012 (GDUFA) 

What is GDUFA and why was it implemented by FDA?
  • 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.
  • Under GDUFA, certain facilities, sites, and organizations must self-identify and may be Subject to user fees.
  • GDUFA requires industry to pay user fees, which will supplement the costs of reviewing generic drug applications and inspecting facilities.
  • 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.
  • 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.  
  •  GDUFA will also enhance global supply chain safety by requiring that generic drug facilities and sites around the world self-identify. 

Self-Identification:  All the facilities which manufacture, or intend to manufacture, human generic drug APIs or FDFs, or both are required to self-identify. Under GDUFA, Self-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.

The Facilities/ Entities/Sites/ Organizations which are not required to pay annual facility fee -
  • Generic entities that solely manufacture positron emission tomography (PET) drugs
  • Clinical bioequivalence or bioavailability study sites
  • In vitro bioequivalence testing or bioanalytical testing sites
  • Active pharmaceutical ingredient (API)/finished dosage form (FDF) analytical testing sites
  • Packagers and repackagers.

Penalty for failure to self-identify: 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.

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.

The various types of GDUFA fees, which were effective on October 1st 2012, are listed below-
Back log Fee- The ANDA, that has not been withdrawn, which has been under review, got tentative approval, that was submitted as on September 28th, 2012 is considered for back log fee. The FDA calculated the fee as $17,434.

DMF Fee- 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 $21,340. It is a one-time fee for each individual DMF, incurred on first reference of the DMF on or after Oct. 1, 2012..

ANDA and PAS Fee- The ANDA which is filed with FDA on or after October 1st, 2012 is considered for ANDA fee. The ANDA fee for year 2013 is calculated as $51,520. PAS fee 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. The PAS fee for year 2013 is calculated as $25,760. The PAS fee is half the fee of new ANDA

FDA’s Refuse to File Policy with respect to GDUFA
  • 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.
  •  Failure to pay an ANDA fee within 20 calendar days of the applicable due date will result in the ANDA not being received.
  • 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.
  • 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.
  • 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.

My Take on GDUFA:
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.

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.

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.

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.

References –

Rajesh Yelugoila

Tuesday, 2 October 2012

How to get a job in the field of Regulatory Affairs ?

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 !

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). 

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!

The information which I learnt, while I worked on Regulatory One, helped  me to get my 2nd job.

Gaining Skills in Regulatory Affairs - 
  • If  you have done (not in RA)- My suggestion would  be-do a diploma/PG diploma course related to RA through part-time/distance. My personally preferred course and institute is PG Diploma in Pharmaceutical Regulatory Affairs from  Jamia Hamdard University since it is 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.
  •  If  you are B. Pharmacy graduate and want to make a career in RA -I would recommend you to do M.Pharmacy in Pharmaceutical RA .
         The list of institutes offering M.Pharmacy in RA are given in the below link.
  •  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.       
  • In FDA's website there are links like CDER learn , Educational Resources and Webinars 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 !
  • Among all the ICH guidelines- M4 (and allied guidelines M4Q, M4S, M4S), Q1A , Q1E ,Q2Q3AQ3BQ3CQ6A are the most important references for RA professionals. Knowing them is very important. 
  • 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.
  • The below listed link is very useful at the time of interview, especially for beginners (freshers).            

Writing Skills -
  • 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. 
Resume -  
  • 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.
  • Upload your resume in job websites like Monster and Naukri. Ensure to fill up all your details and have a complete profile.

Networking 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-
  • Have your detailed profile, with special emphasis on your educational qualification, skills related to regulatory affairs. 
  • Ensure that the information is given in a properly structured manner, without any grammatical errors.
  • 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!
  • 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.
  • 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.
General MisconceptionsI 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 ?

Guys, a person who is a fresher (beginner) can get a job in RA. The best example is, myself !

Hope, the above article will help you in getting a job in the field of Regulatory Affairs. 

Best of Luck! 

  • The above article is intended, mainly for the people from India, who are interested to make a career in the field of RA.
  • I am not in a position where I could refer/recommend for a job. So, kindly do not email me your resumes.