Explanation of terms related to Regulatory Affairs

In this post I am going to define and explain the terms which I referred to in the previous post (Introduction to Regulatory affairs) .These terms are most frequently asked in interviews, so make note of them.


Investigation new drug application (INDA) - It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA.


There are three IND types:


An Investigator INDA- is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.  A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.


Emergency use INDA- Allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with  21CFR ,Sec. 312.23 or Sec. 312.34.  It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.

Treatment IND- is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.

There are two IND categories:

• Commercial
• Research (non-commercial)

The IND application must contain information in three broad areas:

• Animal Pharmacology and Toxicology Studies
• Manufacturing Information
• Clinical Protocols and Investigator Information

The link in FDA's website which gives complete information about INDA is http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm


New Drug Application (NDA) :


The FDA defines it as "The NDA application is the vehicle through which drug sponsors 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  become part of the NDA."


The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:

• Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

• Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.

• 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.

In simple terms - "NDA is an application which is filed with the FDA by a pharma company for getting  approval for their newly discovered drug".

The link in FDA's website which gives complete information about NDA is -http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm

Abbreviated New Drug Application (ANDA):  is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.

A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.  All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

The link in FDA's website which gives complete information about ANDA is http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm

Marketing authorisation application (MAA): is an application (to the relevant authority ; typically the UK's MHRA or the European Commission's Committee for Medicinal Products for Human Use (CHMP) to market a drug or medicine.

The U.S. Food and Drug Administration equivalent of Marketing authorisation application (MAA) is a New Drug Application (NDA).


The link in MHRA's website which gives complete information about MAA is http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Marketingauthorisations/index.htm

Active Pharmaceutical Ingredient (API) (or Drug Substance):

Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product.  Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Active Substance Master File (ASMF)/Drug Master File (DMF) : is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. It is known as European Drug Master File (EDMF) or Active Substance Master File (ASMF) and US-Drug Master file (US-DMF) in Europe and United States respectively.

The DMF contains factual and complete information on a drug product's chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.

Current good Manufacturing Practice (cGMP) : are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. 

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

Good Clinical Practice (GCP): is an international quality standard that is provided by International Conference on Harmonisation (ICH), that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

Good Laboratory Practice (GLP):  specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) safety and efficacy tests.