Regulatory Affairs in the Pharmaceutical Industry

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference compiling all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the contents cover new drug, generic drug and their development, regulatory filings in different countries, different phases of clinical trials and submitting regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). The book will also impart the knowledge about the manufacturing controls and their regulatory importance. The initial chapter cover documentation in the pharmaceutical industry. Then generic drugs product development is presented, followed by Code of Federal Regulation (CFR). Chapter four covers ANDA regulatory approval process, followed by NDA approval process in chapter five. Chapter six presents post-marketing surveillance. Chapter seven describe the process and documentation for US registration of foreign drugs. Next, chapter eight, presents the regulation of combination products and medical devices. Chapter nine describes the CTD and ECTD formats. Chapter ten provides an overview of regulatory guidelines of ICH-Q, S E, M. Next regulatory requirements in the EU, MHRA, TGA, and ROW countries are discussed. Chapter 12 covers global submission of IND, NDA, and ANDA documents. The subject of the following chapter is the dossier of investigation of medicinal products. The two last chapters are regulatory affairs in clinical trials, and pharmacovigilance safety monitoring, respectively. Regulatory Affairs in the Pharmaceutical Industry is the perfect reference for researchers based both in academia or industry willing to understand the complex documentation and approval processes round new drug approvals and regulation. Students in Pharmaceutical Science may also benefit of the practical advice and comprehensive overview of the documentation presented by the editors. Updated reference on drug approval processes on key global marketsComprehensive coverage of concepts of regulatory affairsConcise compilation of regulatory requirements of different countriesIntroduces fundamentals of manufacturing controls and their regulatory importance