SlideShare a Scribd company logo

COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW

P
Pristyn Research Solutions

The document provides an overview of common job interview questions and answers related to drug regulatory affairs, explaining the roles and goals of regulatory affairs professionals in the pharmaceutical industry. It details various applications like NDA, ANDA, IND, and MAA, along with definitions of key terms such as DMF, ASMF, CTD, and guidelines for submission. Additionally, it outlines important regulations such as the Hatch-Waxman Act and the procedures for drug approval both in the U.S. and Europe.

Law
Related topics:
Clinical Research Overview • Job Search Strategies • Interview Questions • Clinical Trials
1 of 34
Downloaded 179 times
1
2
Most read
3
Most read
4
Most read
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW info@pristynresearch.com pristynresearch.com By: Pristyn Research Solutions 9028839789 9607709586
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. What are the goals of Regulatory Affairs Professionals? Ans- •Protection of human health •Ensuring safety, efficacy and quality of drugs •Ensuring appropriateness and accuracy of product information What is an Investigational New Drug (IND) application? Ans- It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA
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 Regulatory Affairs professionals play. What is a New Drug Application? Ans- 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”
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 “ 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. What is a Marketing Authorization Application? Ans- It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine. As per UK’s MHRA- Applications for new active substances are described as 'full applications'. Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’.
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 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. 420 •It is not required when applicant references its own information What is a 505 (b)(2) application ? Ans- 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.
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: FDAAccepted Reference Information (FDA discourages its use) What kind of application can be submitted as a 505(b)(2) application? Ans- •New chemical entity (NCE)/new molecular entity (NME) •Changes to previously approved drugs
What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted ? Ans- •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
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 13.What are the chemical classification codes for NDA? Ans-
S.No. New Drug Application (NDA) 505 (b)(2) Application 1. 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 approval were not conducted by/for applicant and for which applicant has not obtained a right of reference 2. Generally, filed for newly invented pharmaceuticals. Generally, filed for new dosage form, new route of administration, new indication etc for all already approved pharmaceutical. What are the differences between NDA and 505 (b)(2) application ? Ans- Note: 505 (b)(2) application is a type of NDA.
What is a Marketing Authorization Application? Ans- It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine. As per UK’s MHRA- Applications for new active substances are described as 'full applications'. Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’. 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)”.
What are the types of active substances for which ASMFs are submitted? Ans- •New active substances •Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State •Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State 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 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.
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. What are the ICH guidelines to be referred for preparation of registration dossiers/applications of medicines (With respect to format and contents in each module)? Ans- M4 Guideline M4Q Guideline M4S Guideline M4E Guideline
What are the modules in CTD? Ans- The Common Technical Document is divided into five modules: Module 1. Administrative information and prescribing information Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5) Module 3. Quality Module 4. Nonclinical Study Reports (toxicology studies) Module 5. Clinical Study Reports (clinical studies) 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.
What is Hatch-Waxman act? Ans-It is the popular name for Drug Price Competition and Patent Term Restoration Act, 1984. It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file Abbreviated New Drug Application (ANDA) to seek FDA approval of generic drugs. Paragraph IV of the act, allows 180 day exclusivity to companies that are the "first-to-file“ an ANDA against holders of patents for branded counterparts. In simple words “Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics ” What are the patent certifications under Hatch-Waxman act? Ans-As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the “Orange Book” for the innovator drug. This certification must state one of the following: (I) that the required patent information relating to such patent has not been filed (Para I certification); (II) that such patent has expired (Para II certification); (III) that the patent will expire on a particular date (Para III certification); or (IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought(Para IV certification). A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.
What is meant by 180 day exclusivity? Ans-The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit. 180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor ( Atorvastatin calcium). What are the procedures for Approval of Drug in EU?  Centralised Procedure (CP)  Decentralised Procedure (DCP)  Mutual Recognition Procedure (MRP)  National Procedure (NP)
What is the Full form of abbreviation, CEP? Ans- 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) What is a CEP? Ans- 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.
S.N O. ND A # NAME OF DRUG NAME OF ACTIVE INGREDIENT COMPANY 1 203 188 KALYDECO IVACAFTOR VERTEX PHARMS 2 203 388 ERIVEDGE VISMODEGIB GENENTECH 3 202 324 INLYTA AXITINIB PFIZER 4 202 833 PICATO INGENOL MEBUTATE LEO PHARMA AS 5 202 514 ZIOPTAN TAFLUPROST MERCK SHARP DOHME 6 021 746 SURFAXIN LUCINACTANT DISCOVERY LABORATORIES INC What are the recently approved new Drugs by FDA (Under NDA Chemical Type 1)? (As on 14th March, 2012) Ans-
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
Full forms of some of the Abbreviations related to Regulatory Affairs- 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 approval changes 24 BACPAC Bulk Active Chemicals Post approval Changes 25 cGMP Current good Manufacturing Practice 26 GCP Good clinical Practice 27 GLP Good Laboratory Practice
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 Products 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 Surveillance 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) Well known Drug Regulatory Agencies across the world-
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)”. What are the types of active substances for which ASMFs are submitted? Ans- •New active substances •Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State •Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State
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 S.NO. NDA # NAME OF DRUG NAME OF ACTIVE INGREDIENT COMPANY 1 203188 KALYDECO IVACAFTOR VERTEX PHARMS 2 203388 ERIVEDGE VISMODEGIB GENENTECH 3 202324 INLYTA AXITINIB PFIZER 4 202833 PICATO INGENOL MEBUTATE LEO PHARMA AS 5 202514 ZIOPTAN TAFLUPROST MERCK SHARP DOHME 6 021746 SURFAXIN LUCINACTANT DISCOVERY LABORATORIES INC What are the recently approved new Drugs by FDA (Under NDA Chemical Type 1)? (As on 14 th March, 2012) Ans-
What are the modules in CTD? Ans- The Common Technical Document is divided into five modules: Module 1. Administrative information and prescribing information Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5) Module 3. Quality Module 4. Nonclinical Study Reports (toxicology studies) Module 5. Clinical Study Reports (clinical studies) 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.
What are the procedures for Approval of Drug in EU? Ans-  Centralised Procedure (CP)  Decentralised Procedure (DCP)  Mutual Recognition Procedure (MRP)  National Procedure (NP) What is the Full form of abbreviation, CEP? Ans- 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)
What Are The Roles Of Regulatory Affairs Professionals? Answer : •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.
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: FDAAccepted Reference Information (FDA discourages its use) 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)”.
What Is The Full Form Of Abbreviation, Cep? Ans :  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) What Is A Cep? Ans 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.
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW
For Job Oriented Regular / Weekend /Online Certified Industrial Training | Internship & Short Term Courses with placements assistance and guarantee Kindly call us Check
Pharmacovigilance | Clinical Research | Clinical Data Management Drug Regulatory Affairs | Pharma Q.A / Q.C | Pharma Production Pharma Digital Marketing | R & D | Medical Coding Medical Transcription | Medical Writing | Research Publications
LAST
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW

More Related Content

PPTX
overview of Japan pharmaceutical regulatory authority - PMDA
Nandhanan
 
PDF
Pharma regulatory affairs
Girish Swami
 
PPTX
Basic concepts about regulatory affairs
Rajkumar Koley
 
PPT
Regulatory affairs-Introduction to CTD
Mahesh shinde
 
PPTX
Dossier Management and Regulatory Affairs.
Naila Kanwal
 
PPTX
Electronic submission PPT
Doninder Hooda
 
PDF
New drug approval ppt
Prasad Bhat
 
PPTX
Pharmaceutical Dossier submission
sandeep bansal
 
overview of Japan pharmaceutical regulatory authority - PMDA
Nandhanan
 
Pharma regulatory affairs
Girish Swami
 
Basic concepts about regulatory affairs
Rajkumar Koley
 
Regulatory affairs-Introduction to CTD
Mahesh shinde
 
Dossier Management and Regulatory Affairs.
Naila Kanwal
 
Electronic submission PPT
Doninder Hooda
 
New drug approval ppt
Prasad Bhat
 
Pharmaceutical Dossier submission
sandeep bansal
 

What's hot (20)

PDF
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!
Pristyn Research Solutions
 
PPTX
Abriviated new drug application 505(j) filling
shahnawazQuadir
 
PPTX
Regulatory authority of japan
AadityaThole
 
PPTX
Documentation in Pharmaceutical Industry
Navaneethakrishnan Palaniappan
 
PPTX
regulatory requirement for bioequivalence
lamrin33
 
PPT
ctd and e ctd submission
Rohit K.
 
PPTX
ICH [ Q ] Guidelines
AbhishekPatil387
 
PPTX
Regulatory requirement for approval of Biologics
Arpitha Aarushi
 
PPTX
Regulatory guidelines of Australia
nandiniwarier93
 
PDF
MHRA
MD Jahidul Islam
 
PPTX
CDSCO Biologicals - Rules, Regulations, Guidelines and Standards for Regulato...
Mohamed Fazil M
 
PPTX
regulatory requirnment and approval procedure for drugs and cosmetics, medica...
sandeep bansal
 
PDF
eCTD Submissions
Quintiles, Mumbai, India
 
PDF
US and EU Submission – Comparative
Girish Swami
 
PPTX
Regulatory requirements of row countries
Divya Pushp
 
PPTX
THERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRA
Manikant Prasad Shah
 
PPTX
Drug Master Files under GDUFA
GMP EDUCATION : Not for Profit Organization
 
PPTX
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIES
Vikas Rathee
 
PPTX
regulatory approval process of drug, cosmetic and herbals in canada
Richa Patel
 
PPTX
EUROPEAN MEDICAL AGENCY
datchayani
 
COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!
Pristyn Research Solutions
 
Abriviated new drug application 505(j) filling
shahnawazQuadir
 
Regulatory authority of japan
AadityaThole
 
Documentation in Pharmaceutical Industry
Navaneethakrishnan Palaniappan
 
regulatory requirement for bioequivalence
lamrin33
 
ctd and e ctd submission
Rohit K.
 
ICH [ Q ] Guidelines
AbhishekPatil387
 
Regulatory requirement for approval of Biologics
Arpitha Aarushi
 
Regulatory guidelines of Australia
nandiniwarier93
 
MHRA
MD Jahidul Islam
 
CDSCO Biologicals - Rules, Regulations, Guidelines and Standards for Regulato...
Mohamed Fazil M
 
regulatory requirnment and approval procedure for drugs and cosmetics, medica...
sandeep bansal
 
eCTD Submissions
Quintiles, Mumbai, India
 
US and EU Submission – Comparative
Girish Swami
 
Regulatory requirements of row countries
Divya Pushp
 
THERAPEUTIC GOODS ADMINISTRATION (TGA) and MHRA
Manikant Prasad Shah
 
Drug Master Files under GDUFA
GMP EDUCATION : Not for Profit Organization
 
REGULATORY REQUIREMENTS FOR ASEAN COUNTRIES
Vikas Rathee
 
regulatory approval process of drug, cosmetic and herbals in canada
Richa Patel
 
EUROPEAN MEDICAL AGENCY
datchayani
 
Ad

Similar to COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW (20)

PDF
Regulatory Affairs Interview Questions .pdf
PHARMA IQ EDUCATION
 
PPTX
Regulatory requirements for api registration
RiyaRYadav
 
PDF
Fundamental concept of regulatory affairs in pharmaceutical & biotechnology
Hitendra Singh
 
PPTX
US FDA Regulatory Submissions
Chandra Mohan
 
PPTX
5. Unit-V- Regulatory Concepts.
Audumbar Mali
 
PPTX
Regulatory Affairs by Chandra Mohan
Chandra Mohan
 
PPTX
NDA Application.pptx
Venugopal N
 
PPTX
Regulatory requirements for API and Biologics
SimranDhiman12
 
PPTX
Submitting electronic Drug Master Files (DMF) and Active Substance Master Fil...
eCTDconsultancy
 
PPT
DMF by Anthony Crasto
Anthony Melvin Crasto Ph.D
 
PPTX
Documentation In Pharmaceutical Industry
silambarasan I
 
PPTX
REGISTRATION OF INDIAN DRUG PRODUCT IN OVERSEAS MARKET.pptx
Murthujavali Miper
 
PPTX
Introduction to Pharmaceutical Regulatory Affairs.pptx
SrishtiGupta214
 
PPTX
Overview of US FDA: Drugs
Gaurav Andhansare
 
DOCX
NDA_ANDA_IND.docx
ArchiPatel49
 
PPTX
Drug regulation
Abhinab1234
 
PPTX
REGULATORY REQUIREMENTS FOR APPROVAL OF API
nivedithag131
 
PPTX
What are Supergenerics
Anthony Melvin Crasto Ph.D
 
PPTX
US DMF Preparation and submission
Bhanu Chava
 
PPTX
apibiologicsnoveltherapies-220521094211-c5976336.pptx
ManojKumarr75
 
Regulatory Affairs Interview Questions .pdf
PHARMA IQ EDUCATION
 
Regulatory requirements for api registration
RiyaRYadav
 
Fundamental concept of regulatory affairs in pharmaceutical & biotechnology
Hitendra Singh
 
US FDA Regulatory Submissions
Chandra Mohan
 
5. Unit-V- Regulatory Concepts.
Audumbar Mali
 
Regulatory Affairs by Chandra Mohan
Chandra Mohan
 
NDA Application.pptx
Venugopal N
 
Regulatory requirements for API and Biologics
SimranDhiman12
 
Submitting electronic Drug Master Files (DMF) and Active Substance Master Fil...
eCTDconsultancy
 
DMF by Anthony Crasto
Anthony Melvin Crasto Ph.D
 
Documentation In Pharmaceutical Industry
silambarasan I
 
REGISTRATION OF INDIAN DRUG PRODUCT IN OVERSEAS MARKET.pptx
Murthujavali Miper
 
Introduction to Pharmaceutical Regulatory Affairs.pptx
SrishtiGupta214
 
Overview of US FDA: Drugs
Gaurav Andhansare
 
NDA_ANDA_IND.docx
ArchiPatel49
 
Drug regulation
Abhinab1234
 
REGULATORY REQUIREMENTS FOR APPROVAL OF API
nivedithag131
 
What are Supergenerics
Anthony Melvin Crasto Ph.D
 
US DMF Preparation and submission
Bhanu Chava
 
apibiologicsnoveltherapies-220521094211-c5976336.pptx
ManojKumarr75
 
Ad

More from Pristyn Research Solutions (20)

PDF
Pristyn Service
Pristyn Research Solutions
 
PDF
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...
Pristyn Research Solutions
 
PDF
For all fields Common job interview questions with answers updated in 2022.
Pristyn Research Solutions
 
PPTX
Basics of scientific research writing
Pristyn Research Solutions
 
PPTX
Interview soft skills workplace ethics job attire guide grooming, makeover &a...
Pristyn Research Solutions
 
PPTX
IDEAL Ph.D. SEMINAR VIVA PPT- CHEMISTRY
Pristyn Research Solutions
 
PPTX
Communication & Soft Skills in Pharmacy ideal presentation!
Pristyn Research Solutions
 
PPTX
Clinical research
Pristyn Research Solutions
 
PPTX
NEW DRUG DEVELOPMENT
Pristyn Research Solutions
 
PPTX
Ethics committee
Pristyn Research Solutions
 
PDF
JOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENT
Pristyn Research Solutions
 
PDF
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...
Pristyn Research Solutions
 
PDF
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...
Pristyn Research Solutions
 
PDF
FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE INTERVIEW AND ITS PREPARATION
Pristyn Research Solutions
 
PDF
DRUG AND COSMETIC ACT
Pristyn Research Solutions
 
PDF
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS
Pristyn Research Solutions
 
PDF
DRUG ACTION
Pristyn Research Solutions
 
PDF
CDM
Pristyn Research Solutions
 
PPTX
Introduction to clinical research
Pristyn Research Solutions
 
PPTX
Pharmaceutical business management
Pristyn Research Solutions
 
Pristyn Service
Pristyn Research Solutions
 
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...
Pristyn Research Solutions
 
For all fields Common job interview questions with answers updated in 2022.
Pristyn Research Solutions
 
Basics of scientific research writing
Pristyn Research Solutions
 
Interview soft skills workplace ethics job attire guide grooming, makeover &a...
Pristyn Research Solutions
 
IDEAL Ph.D. SEMINAR VIVA PPT- CHEMISTRY
Pristyn Research Solutions
 
Communication & Soft Skills in Pharmacy ideal presentation!
Pristyn Research Solutions
 
Clinical research
Pristyn Research Solutions
 
NEW DRUG DEVELOPMENT
Pristyn Research Solutions
 
Ethics committee
Pristyn Research Solutions
 
JOB INTERVIEW QUESTIONS ASKED IN CLINICAL TRIAL MANAGEMENT
Pristyn Research Solutions
 
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN CLINICAL RESEARCH INTERV...
Pristyn Research Solutions
 
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...
Pristyn Research Solutions
 
FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE INTERVIEW AND ITS PREPARATION
Pristyn Research Solutions
 
DRUG AND COSMETIC ACT
Pristyn Research Solutions
 
PHARMACOVIGILANCE TERMINOLOGIES ASKED IN INTERVIEWS
Pristyn Research Solutions
 
DRUG ACTION
Pristyn Research Solutions
 
CDM
Pristyn Research Solutions
 
Introduction to clinical research
Pristyn Research Solutions
 
Pharmaceutical business management
Pristyn Research Solutions
 

Recently uploaded (20)

PPTX
FFFFFFFFFFFFFFFFFFFFFFTA_012425_PPT.pptx
bLackseaL2
 
PDF
A SEP and FRAND Overview 13 Aug 2024.pdf
Jane Lambert
 
PPTX
Ethiopian Tort Law Short Note by Mikiyas.pptx
awesomeabebe
 
PDF
AHRP LB - Quick Look of the Newly-initiated Koperasi Merah Putih (KMP).pdf
AHRP Law Firm
 
PPT
3. INDUTRIAL RELATIONS INTRODUCTION AND CONCEPTS.ppt
muthukumark49
 
PPT
Understanding the Impact of the Cyber Act
dhanesh96
 
PPTX
UDHR & OTHER INTERNATIONAL CONVENTIONS.pptx
legumleviosa
 
PPTX
RULE_4_Out_of_Court_or_Informal_Restructuring_Agreement_or_Rehabilitation.pptx
sherileeneva3
 
PDF
TRAFFIC-MANAGEMENT-AND-ACCIDENT-INVESTIGATION-WITH-DRIVING-PDF-FILE.pdf
chouziyu14
 
PPTX
Lecture Notes on Family Law - Knowledge Area 5
Frimpong Eric
 
PDF
Analysis Childrens act Kenya for the year 2022
ssuserbc32b91
 
PDF
Notes on Plausibility - A Review of the English and EPO Cases
Jane Lambert
 
PPTX
4-D...Preparation of Research Design.pptx
pacifey700
 
PPTX
Learning-Plan-4-Core-Principles.pptx htts
judekimwellnombre15
 
PPT
Cyber-Crime-in- India at Present day and Laws
rajmohanjangid
 
PPTX
BUSINESS LAW AND IT IN CONTRACT SIGNING AND MANAGEMENT
daudevarist18
 
PPTX
Peter Maatouk Is Redefining What It Means To Be A Local Lawyer Who Truly List...
Maatouks Law Group
 
PDF
250811-FINAL-Bihar_Voter_Deletion_Analysis_Presentation.pdf
sabranghindi
 
PDF
NRL_Legal Regulation of Forests and Wildlife.pdf
yuvanaaramachandran
 
PPTX
Lecture Notes on Family Law - Knowledge Area 5
Frimpong Eric
 
FFFFFFFFFFFFFFFFFFFFFFTA_012425_PPT.pptx
bLackseaL2
 
A SEP and FRAND Overview 13 Aug 2024.pdf
Jane Lambert
 
Ethiopian Tort Law Short Note by Mikiyas.pptx
awesomeabebe
 
AHRP LB - Quick Look of the Newly-initiated Koperasi Merah Putih (KMP).pdf
AHRP Law Firm
 
3. INDUTRIAL RELATIONS INTRODUCTION AND CONCEPTS.ppt
muthukumark49
 
Understanding the Impact of the Cyber Act
dhanesh96
 
UDHR & OTHER INTERNATIONAL CONVENTIONS.pptx
legumleviosa
 
RULE_4_Out_of_Court_or_Informal_Restructuring_Agreement_or_Rehabilitation.pptx
sherileeneva3
 
TRAFFIC-MANAGEMENT-AND-ACCIDENT-INVESTIGATION-WITH-DRIVING-PDF-FILE.pdf
chouziyu14
 
Lecture Notes on Family Law - Knowledge Area 5
Frimpong Eric
 
Analysis Childrens act Kenya for the year 2022
ssuserbc32b91
 
Notes on Plausibility - A Review of the English and EPO Cases
Jane Lambert
 
4-D...Preparation of Research Design.pptx
pacifey700
 
Learning-Plan-4-Core-Principles.pptx htts
judekimwellnombre15
 
Cyber-Crime-in- India at Present day and Laws
rajmohanjangid
 
BUSINESS LAW AND IT IN CONTRACT SIGNING AND MANAGEMENT
daudevarist18
 
Peter Maatouk Is Redefining What It Means To Be A Local Lawyer Who Truly List...
Maatouks Law Group
 
250811-FINAL-Bihar_Voter_Deletion_Analysis_Presentation.pdf
sabranghindi
 
NRL_Legal Regulation of Forests and Wildlife.pdf
yuvanaaramachandran
 
Lecture Notes on Family Law - Knowledge Area 5
Frimpong Eric
 

COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW

  • 1. COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN DRUG REGULATORY AFFAIRS INTERVIEW info@pristynresearch.com pristynresearch.com By: Pristyn Research Solutions 9028839789 9607709586
  • 2. 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. What are the goals of Regulatory Affairs Professionals? Ans- •Protection of human health •Ensuring safety, efficacy and quality of drugs •Ensuring appropriateness and accuracy of product information What is an Investigational New Drug (IND) application? Ans- It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA
  • 3. 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 Regulatory Affairs professionals play. What is a New Drug Application? Ans- 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”
  • 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 “ 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. What is a Marketing Authorization Application? Ans- It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine. As per UK’s MHRA- Applications for new active substances are described as 'full applications'. Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’.
  • 5. 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 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. 420 •It is not required when applicant references its own information What is a 505 (b)(2) application ? Ans- 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.
  • 6. 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: FDAAccepted Reference Information (FDA discourages its use) What kind of application can be submitted as a 505(b)(2) application? Ans- •New chemical entity (NCE)/new molecular entity (NME) •Changes to previously approved drugs
  • 7. What are the examples of changes to approved drug products for which 505(b)(2) application should be submitted ? Ans- •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
  • 8. 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 13.What are the chemical classification codes for NDA? Ans-
  • 9. S.No. New Drug Application (NDA) 505 (b)(2) Application 1. 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 approval were not conducted by/for applicant and for which applicant has not obtained a right of reference 2. Generally, filed for newly invented pharmaceuticals. Generally, filed for new dosage form, new route of administration, new indication etc for all already approved pharmaceutical. What are the differences between NDA and 505 (b)(2) application ? Ans- Note: 505 (b)(2) application is a type of NDA.
  • 10. What is a Marketing Authorization Application? Ans- It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine. As per UK’s MHRA- Applications for new active substances are described as 'full applications'. Applications for medicines containing existing active substances are described as 'abbreviated’ or ‘abridged applications’. 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)”.
  • 11. What are the types of active substances for which ASMFs are submitted? Ans- •New active substances •Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State •Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State 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 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.
  • 12. 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. What are the ICH guidelines to be referred for preparation of registration dossiers/applications of medicines (With respect to format and contents in each module)? Ans- M4 Guideline M4Q Guideline M4S Guideline M4E Guideline
  • 13. What are the modules in CTD? Ans- The Common Technical Document is divided into five modules: Module 1. Administrative information and prescribing information Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5) Module 3. Quality Module 4. Nonclinical Study Reports (toxicology studies) Module 5. Clinical Study Reports (clinical studies) 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.
  • 14. What is Hatch-Waxman act? Ans-It is the popular name for Drug Price Competition and Patent Term Restoration Act, 1984. It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file Abbreviated New Drug Application (ANDA) to seek FDA approval of generic drugs. Paragraph IV of the act, allows 180 day exclusivity to companies that are the "first-to-file“ an ANDA against holders of patents for branded counterparts. In simple words “Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics ” What are the patent certifications under Hatch-Waxman act? Ans-As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants should include certifications in their applications for each patent listed in the “Orange Book” for the innovator drug. This certification must state one of the following: (I) that the required patent information relating to such patent has not been filed (Para I certification); (II) that such patent has expired (Para II certification); (III) that the patent will expire on a particular date (Para III certification); or (IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought(Para IV certification). A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved when the patent expires.
  • 15. What is meant by 180 day exclusivity? Ans-The Hatch-Waxman Amendments provide an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and thereby runs the risk of having to defend a patent infringement suit. 180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor ( Atorvastatin calcium). What are the procedures for Approval of Drug in EU?  Centralised Procedure (CP)  Decentralised Procedure (DCP)  Mutual Recognition Procedure (MRP)  National Procedure (NP)
  • 16. What is the Full form of abbreviation, CEP? Ans- 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) What is a CEP? Ans- 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.
  • 17. S.N O. ND A # NAME OF DRUG NAME OF ACTIVE INGREDIENT COMPANY 1 203 188 KALYDECO IVACAFTOR VERTEX PHARMS 2 203 388 ERIVEDGE VISMODEGIB GENENTECH 3 202 324 INLYTA AXITINIB PFIZER 4 202 833 PICATO INGENOL MEBUTATE LEO PHARMA AS 5 202 514 ZIOPTAN TAFLUPROST MERCK SHARP DOHME 6 021 746 SURFAXIN LUCINACTANT DISCOVERY LABORATORIES INC What are the recently approved new Drugs by FDA (Under NDA Chemical Type 1)? (As on 14th March, 2012) Ans-
  • 18. 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
  • 19. Full forms of some of the Abbreviations related to Regulatory Affairs- 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 approval changes 24 BACPAC Bulk Active Chemicals Post approval Changes 25 cGMP Current good Manufacturing Practice 26 GCP Good clinical Practice 27 GLP Good Laboratory Practice
  • 20. 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 Products 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 Surveillance 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) Well known Drug Regulatory Agencies across the world-
  • 21. 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)”. What are the types of active substances for which ASMFs are submitted? Ans- •New active substances •Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State •Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State
  • 22. 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 S.NO. NDA # NAME OF DRUG NAME OF ACTIVE INGREDIENT COMPANY 1 203188 KALYDECO IVACAFTOR VERTEX PHARMS 2 203388 ERIVEDGE VISMODEGIB GENENTECH 3 202324 INLYTA AXITINIB PFIZER 4 202833 PICATO INGENOL MEBUTATE LEO PHARMA AS 5 202514 ZIOPTAN TAFLUPROST MERCK SHARP DOHME 6 021746 SURFAXIN LUCINACTANT DISCOVERY LABORATORIES INC What are the recently approved new Drugs by FDA (Under NDA Chemical Type 1)? (As on 14 th March, 2012) Ans-
  • 23. What are the modules in CTD? Ans- The Common Technical Document is divided into five modules: Module 1. Administrative information and prescribing information Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5) Module 3. Quality Module 4. Nonclinical Study Reports (toxicology studies) Module 5. Clinical Study Reports (clinical studies) 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.
  • 24. What are the procedures for Approval of Drug in EU? Ans-  Centralised Procedure (CP)  Decentralised Procedure (DCP)  Mutual Recognition Procedure (MRP)  National Procedure (NP) What is the Full form of abbreviation, CEP? Ans- 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)
  • 25. What Are The Roles Of Regulatory Affairs Professionals? Answer : •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.
  • 26. 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: FDAAccepted Reference Information (FDA discourages its use) 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)”.
  • 27. What Is The Full Form Of Abbreviation, Cep? Ans :  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) What Is A Cep? Ans 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.
  • 31. For Job Oriented Regular / Weekend /Online Certified Industrial Training | Internship & Short Term Courses with placements assistance and guarantee Kindly call us Check
  • 32. Pharmacovigilance | Clinical Research | Clinical Data Management Drug Regulatory Affairs | Pharma Q.A / Q.C | Pharma Production Pharma Digital Marketing | R & D | Medical Coding Medical Transcription | Medical Writing | Research Publications
  • 33. LAST