Course Title DRUG REGULATORY AFFAIRS & GLOBAL REGULATORYREQUIREMENTS

Course Code QA203

Course Credit

Lecture : 05

Practical : 00

Tutorial : 00

Total : 05

Course Objectives

This subject will provide brief and comparative introduction to various regulatory agencies

involving their historical perspectives, organization, structure, activities & responsibilities.

Detailed Syllabus - Theory

Sr.No. Name of Chapter & Details Hours

Allotted

Section-I

1 Regulatory requirement in pharmaceutical analysis – US-FDA, ICH 04

2 Basics in Drug approval process with reference to:

Orange book, Freedom of information, IIG, Historical aspects with

various phases of drug development and approval.

04

3 Registration of drugs in overseas markets: Technical documentation,

dossiers, CTD. Guide lines for filing in countries like India, Japan, US & EU

06

4 IND: submission, format & content of IND, content of Investigator. 04

5 Brochure, general consideration of New Drug Approval (NDA), specific

requirements, content & format of NDA, manufacturing control

requirement of NDA.

04

6 ANDA: Concept of para I to IV, exclusivity: Content, format, development

flow sheet and application.

05

7 Quality safety and legislation for cosmetic and herbal products. 03

8 Fundamentals of Regulatory Sciences:

ICH and WHO guideline for Quality, safety and efficacy

08

Section-II

9 Study of compendia – Evolution, Study of parts of compendia like:

Policies, General notices, Monographs, Comparative picture of IP, BP,

USP, EP & JP.

07

10 Brief and comparative introduction to various regulatory agencies

(Historical perspectives, organization, structure, activities &

responsibilities): US-FDA, TGA, MHRA, MCC, Canadian HPFBI, EMA,

ASEAN, KFDA (Korea), PMDA (Japan), GCC (Gulf Co-operation Council),

ANVISA, etc.

10

11 Introduction to various standard institutions (Historical perspectives,

organization, structure, activities & responsibilities): WHO, ICH, ISO, BSS,

07

ASTM, OSHA, PIC/S (Pharmaceutical Inspection Convention and

Pharmaceutical Inspection Co-operation Scheme) etc.

12 National accreditation Board for testing and calibration laboratory

(NABL) certification and licensing and accreditation procedure for drug

industry.

O4

13 Industrial safety and health, Occupational health hazards, safety

procedures and waste disposal, scrap disposal procedures and records.03

14 Drug Master File (Case Study) 02

15 Material Safety Data Sheet (MSDS) preparation 02

16 Orphan Drug 02

Instructional Method and Pedagogy:

Lectures will be conducted with the aid of multi-media projector, black board, OHP etc.

Assignments based on course content will be given to the students at the end of each

unit/topic and will be evaluated at regular interval.

Surprise tests/Quizzes/Seminar/Tutorials will be conducted.

The course includes language practices such as Group Discussion, Interviews etc. to

develop the communication skills of the students.

Students Learning Outcomes:

This subject gives details about guidelines and procedures for application of investigational

drug, new drug and abbreviated new drug in various countries and provide brief and

comparative introduction to various regulatory agencies involving their historical

perspectives, organization, structure, activities & responsibilities.

Text Books:

1. Mittal B.M., A Textbook of Forensic Pharmacy, 9th Ed., Vallabh Prakashan

2. Forensic Pharmacy by B.S. Kuchekar, A. M. Khadatare and S. C. Jitkar, 6th Ed., Nirali

Prakashan

3. Drug regulatory affairs by Sachin Itkar, Nirali Prakashan.

Reference Books:

1. Industrial Health and Safety, Dr. A.M. Sharma, Himalaya Publication.

2. Good laboratory Practices – Marshell Deckker Series

3. Good clinical Practices: Standard Operating Procedures for clinical Researchers, Wiley.

4. New drug approval process: Accelerating Global registrations By Richard A. Guarino,

MD, 5th edition, Drugs and the pharmaceutical sciences, Vol. 190.

5. Guidebook for drug regulatory submissions/ Sandy Weinberg By John Wiley & Sons.

INC.

6. FDA regulatory affairs: A guide for prescription drugs, medical devices, and

biologics/edited by Douglas J. Pisano, David Mantus.

7. Drugs from discovery to approval, Second edn, by Rick N. G.

8. New drug development: A regulatory overview, 8th edn, by Mark Mathieu

9. Preparation and maintenance of the IND application in eCTD Format by William K.

Sietsema

10. Medical product regulatory affairs: Pharmaceuticals, Diagnostics, medical devices by

John J. Tobin and gary Walsh

11. Drugs and Cosmetics Laws by Krishnan Arora, Professional Book Publishers, New Delhi

12. Gnarino Richard A, New Drug Approval Process, 3rd Ed., Marcel Dekker Inc.

13. P. Warayan, Intellectual Property Laws, Eastern Law House.

14. Ira R. Bery, “Introduction to the Pharmaceutical Regulatory Process”, Drugs and Pharm

Sci. Series, Vol. 144, Marcel Dekker Inc., N.Y.

15. Indian Pharmacopoeia, Vol. 1-3, 2007.The Indian Pharmacopoeia commission,

Gahaziabad, Govt. of India.

16. The International Pharmacopoeia Vol-1,2,3,4,5, 3rd Edition.

17. “WHO Expert Committee on specification on Pharmaceutical Preparation” 34th

report, Geneva, World Health Organisation, 1996 (WHO Technical Report Series, No.

863

18. Quality Assurance of Pharmaceuticals – A compendium of guidelines and related

materials Vol.1 and Vol.2, WHO, (1999)

19. A. C. Cartwright and Brian Mathews, “International Pharmaceutical Registration”

Taylor and Francis Ltd. UK, 2002

20. United State Pharmacopoeia (USP) 32, NF27, 2009

21. Drugs and Cosmetics Laws by Krishnan Arora, Professional Book Publishers, New Delhi

Additional Resources

1. Various research journals, magazine, official websites of regulatory agencies and other

internet sources.