This book provides an overview of drug development and regulatory affairs covering the lifecycle from discovery to market approval, global trade impacts, and regulatory frameworks. It explores clinical testing guidelines, bioethics, and pharmacovigilance. This book is valuable for professionals and researchers of pharmaceutical sciences.
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.
Chapter1. Stages and Processes in Drug Development and Discovery.
Chapter
2. The 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 & 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 U.S 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 Pharmacueticals.
Chapter
14.
Regulatory Sciences in Emerging Markets of Rest of The World (Row).
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.
Nimisha Srivastava has been working as an Associate Professor at the Amity Institute of Pharmacy, Amity University Uttar Pradesh, Lucknow Campus since August 2008. She has over 16 years of teaching and research experience. She has more than 50 publications of international and national repute, focusing on novel drug delivery systems, dermatological disorders such as psoriasis, dermatitis, inflammation, and wound healing, as well as nano vesicular systems like ethosomes and transferosomes for herbal phytoconstituents, and nanocrystals for the treatment of breast and skin cancer. She was selected to present her innovation titled "Herbal Remedy for Psoriasis" at the Bio-Tech Startup Expo-2022 (BIRAC) Innovation towards Aatma Nirbhar Bharat on June 9, 2022, at Pragati Maidan, New Delhi. In 2019, she was awarded the Best Researcher Award for her work on "Herbal Remedies for Dermatological Disorders" by the Society of Biotechnologists of India.
Neeraj Mishra has been working as a Professor at Amity Institute of Pharmacy, Gwalior, since July 2019. He has around twenty years of teaching and research experience. He has more than 100 publications of international and national repute on recent concepts of novel drug delivery systems, oral delivery of synbiotics, localized drug delivery, and targeted and controlled drug delivery of nanocarriers and microparticles for the treatment of breast, colon, and neurodegenerative disorders. He has also edited 10 books and authored 25 book chapters. He has been granted three international patents and two Indian patents. Dr. Mishra is the recipient of the Distinguished Professor Award 2019 from DST-NSTMIS, SPAICS, Indore, and M.P. in September 2019. Dr. Mishra has also received the Outstanding Scientist Award '' 2020, 6th International Scientist Awards on Engineering, Science, and Medicine, 2021 June 2020, Chennai, India. He has received the Distinguished Professor Award '' 2021 from the Indian Pharmaceutical Association, MP State Branch, Indore. Further, he has received the Best Academician Award in the Indian Pharmacy Graduate Association, M.P. State International Conference held on May 6, 2023, at DAVV Auditorium, Indore, India.
Sumel Ashique has been working as an Assistant Professor at the Pandaveswar School of Pharmacy in Pandaveswar, India. He has three years of teaching experience and has published more than 45 research articles in internationally and nationally accredited, reputed journals. He has been working in targeted drug delivery, nanotechnology, and infection disorders. He has also been granted four patents from IP and Australia and has authored more than 18 book chapters.
Bharanitharan Rajendran is an experienced professional with over a decade of dedicated expertise in the Life Sciences industry, specializing in Compliance, Quality Assurance, and Validation for GxP systems. His journey in this field spans from the earliest stages of Clinical Trials through to Post Market reporting, covering a wide spectrum of critical systems including Clinical Operations, Clinical Data Management, Regulatory Reporting, Safety & Adverse Event Reporting, Medical Affairs, Pharmacovigilance, Supply Chain, and ERP SAP systems. As a Certified Internal ISO27001 Auditor, Bharanitharan has a proven track record of successfully implementing Information Security Management Systems following ISO27001/ISO27002 standards.
