Knowledge sharing platform: Regulatory affairs_Part 001

Dear All,

We are starting a new series on knowledge sharing from today. In this series, we would share relevant articles in the field of pharmaceutical industry.

 

Recently received an email sharing the information relating to regulatory affairs activities in pharmaceutical industry. We are reproducing the same for our readers.

 

1. What is Regulatory Affairs?

Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing.

2. What are the goals of Regulatory Affairs Professionals?

Protection of human health Ensuring safety, efficacy and quality of drugs Ensuring appropriateness and accuracy of product information.

3. What are the Roles of Regulatory Affairs professionals?

Act as a liaison with regulatory agencies Preparation of organized and scientifically valid NDA, ANDA,INDA ,MAA,DMF submissions Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans Advising the companies on regulatory aspects and climate that would affect their proposed activities Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.

4. What is an Investigational New Drug (IND) application?

It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA

5. What is a New Drug Application?

The NDA 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. In simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in USA”

6. What is an Abbreviated New Drug Application (ANDA)?

It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug. In simple words, “It is an application for the approval of Generic Drugs “

7. What is a Generic Drug Product?

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.

8. What is a DMF?

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.

Important facts regarding DMFs:

It is submitted to FDA to provide confidential information. Its submission is not required by law or regulations. It is neither approved nor disapproved. It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these. It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420It is not required when applicant references its own information

9. What are the types of DMFs?

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information (FDA discourages its use)

10. What is a 505 (b)(2) application ?

505 (b)(2) application is a type of NDA for which one or more investigations relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference.

11. What kind of application can be submitted as a 505(b) (2) application?

New chemical entity (NCE)/new molecular entity (NME)

Changes to previously approved drugs

12. What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted ?

·         Change in dosage form

·         Change in strength

·         Change in route of administration Substitution of an active ingredient in a formulation product

·         Change in formulation

·         Change in dosing regimen

·         Change in active ingredient

·         New combination Product

·         New indication

·         Change from prescription indication to OTC indication

·         Naturally derived or recombinant active ingredient

·         Bioinequivalence

13. What are the chemical classification codes for NDA?

Number	Meaning
1	New molecular entity (NME)
2	New ester, new salt, or other noncovalent derivative
3	New formulation
4	New combination
5	New manufacturer
6	New indication
7	Drug already marketed, but without an approved NDA
8	OTC (over-the-counter) switch

14. What are the differences between NDA and 505 (b)(2) application?

New Drug Application	505 (b)(2) Application
All investigations relied on by applicant for approval were conducted by/for applicant and for which applicant has right of reference.	One or more investigation relied on by applicant for approvals were not conducted by/for applicant and for which applicant has not obtained a right of reference.
Generally, filed for newly invented pharmaceuticals.	Generally, filed for new dosage form, new route of administration, new indication etc for all already approved pharmaceuticals.

Note: 505 (b) (2) application is a type of NDA.