Pharmaceutical Regulatory Affairs

Principles and Practices

Nimisha Srivastava, Neeraj Mishra, Sumel Ashique, Bharanitharan Rajendran

• Publisher: CRC Press
• Year: 2025
• eBook ISBN:
  9781040644492
• Topic: Medicine
• Subtopic: Philosophy & Ethics in Science

This book provides concepts, procedures, guidelines, and regulatory affairs in drug development. Pharmaceutical Regulatory Affairs: Principles and Practices begins with a detailed overview of the drug development life cycle, from initial discovery and preclinical research to clinical trials and market approval, addressing scientific, regulatory, and ethical considerations at each stage. The book covers the evolution of global trade agreements like the General Agreement on Tariff and Trades (GATT) and the World Trade Organization's (WTO) impact on pharmaceuticals, highlighting issues surrounding pharmaceutical patents and intellectual property rights. It discusses the importance of the Scale-Up and Post-Approval Changes (SUPAC) guidelines in ensuring quality and consistency in drug manufacturing post-approval and examines the World Health Organization's (WHO) guidelines on technology development and transfer. The fundamentals of regulatory affairs are covered, emphasizing the roles and responsibilities of regulatory professionals. The book provides an in-depth look at regulatory frameworks of major agencies worldwide, including the Central Drugs Standard Control Organization (CDSCO) in India, the Food and Drug Administration (FDA) in the US, the European Medicines Agency (EMA) in the EU, the Therapeutic Goods Administration (TGA) in Australia, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, Health Canada, and regulatory authorities in emerging markets. It also addresses the international regulatory landscape for medical devices and reviews foundational pharmaceutical regulations. Additionally, the text explores regulatory guidelines for clinical testing, including the roles and responsibilities under pharmaceutical legislation, principles of bioethics and biosafety, the digital transformation in clinical trials, and the critical role of pharmacovigilance. The book concludes with an examination of the global regulatory scenario for pharmaceutical excipients, providing a detailed roadmap through the complexities of drug development, regulatory compliance, and global standards. This book is valuable for professionals, researchers, and students of pharmaceutical sciences.

Table of contents

• Cover
• Half-Title
• Title
• Copyright
• Contents
• Preface
• About the Editors
• Chapter 1 Stages and Processes in Drug Development and Discovery
• Chapter 2 Historical and Present Perspective on the General Agreement on Tariffs and Trade (GATT)
• Chapter 3 WTO and Its Impact on Pharmaceuticals
• Chapter 4 Pharmaceutical Patents and IPR
• Chapter 5 Understanding the Scale-Up and Post-Approval Changes (SUPAC) Guidelines
• Chapter 6 WHO Guidelines on Technology Development and Transfer
• Chapter 7 Fundamentals of Regulatory Affairs in Pharmaceuticals
• Chapter 8 Regulatory Framework of the Central Drugs Standard Control Organization (CDSCO) in India
• Chapter 9 Regulatory Overview of the US Food and Drug Administration (FDA)
• Chapter 10 Regulatory Framework of the European Medicines Agency (EMA) and EU Member States
• Chapter 11 Regulatory Processes of the Therapeutic Good Administration (TGA) in Australia
• Chapter 12 Regulatory Landscape of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan
• Chapter 13 Health Canada’s Regulatory Framework for Pharmaceuticals
• Chapter 14 Regulatory Sciences in Emerging Markets
• Chapter 15 International Regulatory Authorities for Medical Devices
• Chapter 16 Regulatory Overview Indian Drugs and Cosmetics Act of 1940 and Rules of 1945
• Chapter 17 Responsibilities and Functions under Pharmaceutical Legislation
• Chapter 18 Principles of Bioethics and Biosafety in Pharmaceuticals
• Chapter 19 Digital Transformation in Clinical Trials and Research
• Chapter 20 Pharmacovigilance: Ensuring Safety in Clinical Trials
• Chapter 21 Regulatory Scenario of Excipients Worldwide
• Chapter 22 Innovation through Renovation Navigating Regulatory Framework and Technical Challenges of Drug Repositioning
• Index