Regulatory Affairs interview Questions
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
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
4. What is an Investigational New Drug (IND) application?
It is an application which is filled 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 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
9. What are the types of DMF’s?
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?
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
4. What is an Investigational New Drug (IND) application?
It is an application which is filled 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 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
9. What are the types of DMF’s?
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
0 Comments
If Have Any Queries About Jobs Update You Can Comments Below