REGULATORY
AFFAIRS
P R O F. M A N I S H B A H E T I
G H R U , S A I K H E D A , M . P.

UNIT-III
REGULATORY AFFAIRS
Regulatory Affairs: Introduction, Historical overview of Regulatory
Affairs, Regulatory authorities, Role of Regulatory affairs department,
Responsibility of Regulatory Affairs Professionals
Regulatory requirements for drug approval: Drug Development
Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism
and Toxicology, General considerations of Investigational New Drug (IND)
Application, Investigator’s Brochure (IB) and New Drug Application (NDA),
Clinical research / BE studies, Clinical Research Protocols, Biostatistics in
Pharmaceutical Product Development, Data Presentation for FDA
Submissions, Management of Clinical Studies.

INTRODUCTION
• It is a profession of Regulated Industries
• Combination of Science and Management
• Motive of restoring public health
NEED
To develop most efficient and safe product. Provides guidance.
SCOPE
Pharmaceuticals
Medical devices
In vitro diagnostics
Biologics and biotechnology
Nutritional products
Cosmetics
Veterinary products

FUNCTIONS
• Regulatory and technical Inputs
• Regulatory submissions
• Acts as interface
• Review and submission
• Negotiate

HISTORY
• Sulfanilamide elixir tragedy
• Thalidomide tragedy
• Dalkon shield