Regulatory Affairs-Interview Questions & Answers

Regulatory Affairs-Interview Questions & Answers

1. What is Regulatory Affairs?

Ans-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 Roles of Regulatory Affairs professionals?

Ans- 

• 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 RegulatoryAffairs professionals play.

 

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

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

 

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

Ans- 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 “

 

5. What is a Generic Drug Product?

Ans- 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. 

 

6. What is a DMF?

Ans- 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 filled 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. 420
• It is not required when applicant references its own information

 7. What are the types of DMF’s?

Ans-

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)

 

8. What is an ASMF?

Ans-Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or ‘know-how’ of the manufacturer of the active substance.

In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”.

9. What is the difference between DMF and ASMF (with respect to submission)?

Ans-ASMF is submitted as Applicant’s Part (Open Part) and Restricted Part (Closed Part)

There isn’t any differentiation of DMF’s into parts

 

10. What is ICH?

Ans-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.

 

11. What is CTD?

Ans-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.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc. 

12.What is Orange Book?

Ans-

• It is the commonly used name for the book “Approved Drug Products with Therapeutic Equivalence Evaluations”, which is published by USFDA.

• 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.

 

13. What is the Full form of abbreviation, CEP?

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

It is also informally referred to as Certificate of Suitability (COS)

 

14. What is a CEP?

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.

 

 

 

15. Full forms of some of the Abbreviations related to Regulatory Affairs-

S.No.	Abbreviation	Full Form
1	NDA	New Drug Application
2	ANDA	Abbreviated New Drug application
3	IND	Investigational New Drug Application
4	DMF	Drug Master file
5	ASMF	Active Substance Master File
6	MAA	Marketing Authorisation Application
7	CEP	Certificate of Suitability to the monographs of the European Pharmacopoeia
8	ICH	The International Conference on Harmonisation of technical requirements for registration of Pharmaceuticals for human use.
9	CTD	Common technical document for the registration of pharmaceuticals for human use.
10	AP	Applicant’s Part
11	RP	Restricted Part
12	OP	Open Part
13	CP	Closed Part
14	NME	New Molecular Entity
15	NCE	New Chemical Entity
16	SmPC	Summary of Product Characteristics
17	PL	Packaging Leaflet
18	RMS	Reference Member State
19	CMS	Concerned Member State
20	CHMP	The Committee for Medicinal Products for Human Use
21	CPMP	Committee for Proprietary Medicinal Products
22	CVMP	Committee For Medicinal Products For Veterinary Use
23	SUPAC	Scale-up and post approv al changes
24	BACPAC	Bulk Active Chemicals Post approval Changes
25	cGMP	Current good Manufacturing Practice
26	GCP	Good clinical Practice
27	GLP	Good Labora tory Practice

 

16. Well known Drug Regulatory Agencies across the world-

S.No.	Country /Region	Regulatory Agency
1	United States of America	United States Food and Drug Administration(USFDA)
2	United Kingdom	Medicines and Healthcare products Regulatory Agency (MHRA)
3	European Union	European Medicines Agency (EMA)
4	European Union	European Directorate for the Quality of Medicines(EDQM)
5	Australia	Therapeutic Goods Administration (TGA)
6	Canada	Therapeutic Pro ducts Directorate  (TPD) in Health Product and food branch (HPFB) of Health Canada (HC)
7	Japan	Pharmaceutical and Medical Devices Agency(PMDA)
8	France	Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) Translated into English as-French Agency for the Safety of Health Products
9	Germany	Bundesinstitut für Arzneimittel und Medizinprodukte, (BfArM) Tanslated into English as-Federal Institute for Drugs and Medical Devices
10	Brazil	Agência Nacional de Vigilância Sanitária (ANVISA) Tanslated into English as-The National Health Surv eillance Agency
11	India	Drugs Controller General of India (DCGI) who heads Central Drugs Standard Control Organisation(CDSCO)
12	Switzerland	Swiss Agency for Therapeutic Products(SWISSMEDIC)
14	Singapore	Health Sciences Authority (HSA)
15	New Zealand	New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE)

•