R17 B.
PHARMACY IV YEAR
PS706: PHARMACEUTICAL REGULATORY SCIENCE (Open Elective - III)
[Link]. IV Year I Sem. L/T/P/C
3/1/0/ 4
Course Objectives: This course is designed to impart the fundamental knowledge on the regulatory
requirements for approval of new drugs, drug products in regulated countries like US, EU, Japan,
Australia and Canada. It prepares the students to learn in detail on the regulatory requirements,
documentation requirements, and registration procedures for marketing the drug products in regulated
countries.
Course Outcomes: Upon completion of the subject student shall be able to:
• Know about the process of drug discovery and development
• Know the regulatory authorities and agencies governing the manufacture and sale of
pharmaceuticals
• Know the regulatory approval process and their registration in Indian and international markets
UNIT – I 10 Hours
New Drug Discovery and development
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical
studies, Innovator and generics, Concept of generics, Generic drug product development.
UNIT – II 10 Hours
Regulatory Approval Process: Approval processes and timelines involved in Investigational New
Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA) in US. Changes
to an approved NDA / ANDA.
Regulatory authorities and agencies: Overview of regulatory authorities of United States, European
Union, Australia, Japan, Canada (Organization structure and types of applications)
UNIT – III 10 Hours
Registration of Indian drug product in overseas market: Procedure for export of pharmaceutical
products, Technical documentation, Drug Master Files (DMF), Common Technical Document (CTD),
electronic Common Technical Document (eCTD), ASEAN Common Technical Document (ACTD)
research.
UNIT – IV 08 Hours
Clinical trials: Developing clinical trial protocols, Institutional Review Board / Independent Ethics
committee - formation and working procedures, Informed consent process and procedures, GCP
obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials,
Pharmacovigilance - safety monitoring in clinical trials
UNIT – V 07 Hours
Regulatory Concepts: Basic terminologies, guidance, guidelines, regulations, laws and acts, Orange
book, Federal Register, Code of Federal Regulatory, Purple book
Recommended books (Latest edition):
1. Drug Regulatory Affairs by Sachin Itkar, Dr. N. S. Vyawahare, Nirali Prakashan.
2. The Pharmaceutical Regulatory Process, 2nd Edition Edited by Ira R. Berry and Robert P.
Martin, Drugs and the Pharmaceutical Sciences, Vol.185. Informa Health care Publishers.
3. New Drug Approval Process: Accelerating Global Registrations by Richard A Guarino, MD, 5th
edition, Drugs and the Pharmaceutical Sciences, Vol.190.
4. Guidebook for drug regulatory submissions / Sandy Weinberg. By John Wiley & Sons. Inc.
R17 B. PHARMACY IV YEAR
5. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited
by Douglas J. Pisano, David Mantus.
6. Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer,
Marcel Dekker series, Vol.143
7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance by Fay A.
Rozovsky and Rodney K. Adams
8. Principles and Practices of Clinical Research, 2nd Edition Edited by John I. Gallin and Frederick
P. Ognibene
9. Drugs: From Discovery to Approval, 2nd Edition by Rick N
