Text Book of Regulatory Affairs for the Students of M.Pharm 1st Semester

• Author Details: Prof. (Dr.) Ravinesh Mishra, Dr. Bhartendu Sharma, Dr. Priya Sharma
• ISBN: 978-93-48565-85-3
• Speciality: Regulatory Affairs

“Regulatory Affairs” presents a comprehensive exploration of the principles, practices, and evolving dimensions of pharmaceutical regulatory science. Developed to offer a balanced integration of theoretical foundations and practical applications, the book serves as an essential guide for understanding the global regulatory landscape that governs the development, evaluation, manufacturing, marketing, and post-marketing surveillance of pharmaceutical products. It systematically covers the regulatory frameworks of various national and international authorities, including detailed discussions on the roles and responsibilities of organizations such as the Central Drugs Standard Control Organization (CDSCO), United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), and the International Council for Harmonisation (ICH). Special attention is given to the documentation and regulatory pathways required for new drug approvals, including Investigational New Drug (IND) applications, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and Drug Master Files (DMF).
The book also delves into critical areas such as Intellectual Property Rights (IPR), patent filings, regulatory data protection, and exclusivity provisions, which are vital for innovation and commercial strategy in the pharmaceutical industry. Quality standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) are thoroughly explained, highlighting their significance in ensuring product safety, efficacy, and compliance. The design and ethical conduct of clinical trials, regulatory inspection processes, and pharmacovigilance systems for monitoring drug safety post-approval are also covered in detail. Supported by case studies, real-world examples, and regulatory updates, this book offers practical insights that reflect current industry trends and expectations. Its content is structured to encourage clarity, comprehension, and application, making it a reliable reference for anyone engaged in pharmaceutical development, compliance, or research. Whether used as a foundational resource or a practical manual, the Regulatory Affairs provides readers with the critical knowledge and skills necessary to navigate and succeed in the highly regulated and dynamic pharmaceutical environment.

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