Course Title: 
Pharmaceutical Regulatory Science - Theory
Course Code: 
Year Taught: 
Undergraduate (UG)
School of Pharmacy

'Pharmaceutical Regulatory Science - Theory' is a course offered in the eighth semester of B. Pharm program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Course Duration: 45 Hours


This course is designed to impart the fundamental knowledge on the regulatory requirements for approval of new drugs, and drug products in regulated markets of India & other countries like US, EU, Japan, Australia,UK etc. It prepares the students to learn in detail on the regulatory requirements, docu- mentation requirements, and registration procedures for marketing the drug products.


Upon completion of the subject student shall be able to;

  1. Know about the process of drug discovery and development
  2. Know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals
  3. 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). Changes to an approved NDA / ANDA. Regulatory authorities and agencies: Overview of regulatory authorities of India, United States, Europe- an 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 Com- mon Technical Document (ACTD)research.

Unit IV (08 Hours)

Clinical trials: Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee - forma- tion and working procedures, Informed consent process and procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials, Pharmacovigilance - safetymonitoring in clinical trials

Unit V (07 Hours)

Regulatory Concepts: Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book

Recommended Books (Latest Editions)

  1. Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
  2. The Pharmaceutical Regulatory Process, Second 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 edi- tion, Drugs and the Pharmaceutical Sciences,Vol.190.
  4. Guidebook for drug regulatory submissions / SandyWeinberg. By John Wiley & Sons. Inc.
  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, Mar- cel Dekker series, Vol.143
  7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A. Ro- zovsky and Rodney K. Adams
  8. Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick P. Ognibene
  9. Drugs: From Discovery to Approval, Second Edition By Rick Ng