Pharmaceutical Regulatory Affairs: Principles and Practices

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.

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, 20-21 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.