This book has 12 chapters covering nearly all the areas of Drug Regulatory Affairs. Various aspects of Drug Regulatory Affairs such as new drug approval procedure, pharmacovigilance, product recall, evolution of drug regulations in the United States of America (USA) and process of drug approval in the USA and European Union, bioequivalence regulations, electronic Common Technical Documents (eCTD), environmental regulations, orphan drugs pharmaceutical pricing and control policy, Pharmacovigilance system in India and the USA, Product Recall, regulations of pharmaceutical drug promotion and Pharmacy Practice regulations are covered in this book. As a whole, the book is a comprehensive reference book on regulatory affairs and will be very useful for the practicing professionals and students alike. Dr N Udupa, born in July 1953, completed his post-graduation in 1976, received PhD from Banaras Hindu University, Varanasi, India in 1987. After serving in Pharma Industry for eight years, he has been working in academics for last 30 years. He currently holds the position of Director Research – Health Sciences, Manipal University, Manipal and served as Principal of Manipal College of Pharmaceutical Sciences, Manipal University, Manipal from 1997-2013. He received Principal of the Year (2001) award from APTI. He served as Convener – Scientific Services of Indian Pharmaceutical Congress Association from 2010 to 2012. Dr N Udupa has visited several internationally reputed research laboratories and Universities several countries such as Australia, Singapore, Japan, the US, the UK, Canada, Germany and Switzerland on academic assignments. He is the editor three Pharmacy journals viz., Pharmag, Indian Journal of Hospital Pharmacy and International Journal of Community Pharmacy. He is guiding several MPharm and PhD candidates for research projects sponsored by various government and private funding agencies. Dr Udupa has published more than 400 articles in national and international journals with high impact factor and has also authored eight books. He has nine Indian patents to his credit. Dr Udupa has received best paper awards in national and international Conferences. Dr Udupa is a recipient of several national and international awards. Dr Krishnamurthy Bhat completed his graduation and post-graduation in Pharmacy from JSS College of Pharmacy, Mysore and L M College of Pharmacy, Ahmedabad respectively. He received his PhD from Gujarat University. Dr Bhat worked with Bangalore Pharmaceutical and Research Laboratory, Bangalore as Manager – Quality Assurance. He has worked as a faculty in K B Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat. Dr Bhat was instrumental in establishing bioanalytical section of Manipal Acunova. He is also responsible for establishing postgraduate and research programmes in Pharmaceutical Analysis and Regulatory Affairs in Manipal College of Pharmaceutical Sciences, Manipal University. Currently, he is Professor and Head, Department of Pharmaceutical Quality Assurance at Manipal College of Pharmaceutical Sciences, Manipal University. He has published several national and international research papers, and is supervising post graduate and PhD projects. He has delivered several invited lectures.