The document discusses regulatory affairs, providing an introduction and overview of its history and functions. It describes regulatory affairs as a profession that combines science and management with the goal of restoring public health. The document outlines the scope of regulatory affairs, including pharmaceuticals, medical devices, diagnostics, and other regulated products. It also summarizes some key functions of regulatory affairs such as providing regulatory and technical inputs, preparing submissions, acting as an interface, and negotiating with regulatory authorities.

1. 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.

2. 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.

3. 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

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

5. HISTORY
• Sulfanilamide elixir tragedy
• Thalidomide tragedy
• Dalkon shield