04119nam a22006255i 4500 978-3-031-61901-4 DE-He213 20251030112655.0 cr nn 008mamaa 240728s2024 sz | s |||| 0|eng d 9783031619014 978-3-031-61901-4 10.1007/978-3-031-61901-4 doi K7000-7720.22 LB bicssc LAM bicssc LAW051000 bisacsh LB thema LAM thema Balzano, John C. author. aut http://id.loc.gov/vocabulary/relators/aut 81442 China Food and Drug Law [electronic resource] : Policy, Practice, and Future Directions / by John C. Balzano. 1st ed. 2024. Cham : Springer International Publishing : Imprint: Springer, 2024. XVI, 389 p. online resource. text txt rdacontent computer c rdamedia online resource cr rdacarrier text file PDF rda Law for Professionals, 2662-1428 1. Introduction and Methology -- 2. Agencies involved in China FDD Regulation -- 3. General Administrative Law Concepts and Enforcement Powers -- 4. Common Principles of China FDD Regulation -- 5. Pharmaceutical Regulation -- 6. Medical Device Regulation -- 7. Biosecurity and FDD Research and Development -- 8. Food and Special Food Regulation -- 9. Cosmetics Regulation -- 10. Advertising and Promotion for Regulated Products. This book is an analysis of policy and law governing the development, approval, manufacture, distribution, marketing and post-market surveillance of human drugs, medical devices, foods and cosmetics in Mainland China (“China FDD Regulation”). It analyzes the policy and general principles behind China FDD Regulation, including the history and jurisdiction of the central and local agencies that administer the laws and regulations, the administrative law structure in which these agencies operate, and other aspects of FDD Regulation interpretation and enforcement. Although it describes practice in China, this book is written in the comparative perspective (i.e., sensitive to assumptions made by those who are steeped in FDD Regulation in the U.S., Japan, and the EU). It includes one chapter on each regulatory space (drugs, medical devices, cosmetics, and food) organized by the lifecycle of products. It also covers subcategories of products, such as vaccines, radiopharmaceuticals, and in vitro diagnostic medical devices. The book includes specialty chapters on areas that are common to multiple types of regulated products, such as biosecurity and advertising. It is the first English language book of its kind, and it can serve as a resource for those in the FDD law and regulatory field to understand the mechanics of developing and marketing products, but also with insights for businesspeople and others, who are developing China-strategies. Private international law. 65660 Conflict of laws. 65661 International law. 58292 Comparative law. 65662 Administrative law. Food Safety measures. 61309 Asia Politics and government. 69658 Private International Law, International and Foreign Law, Comparative Law. 65667 Administrative Law. Food Safety. 67660 Asian Politics. 69661 SpringerLink (Online service) Springer Nature eBook Printed edition: 9783031619007 Printed edition: 9783031619021 Printed edition: 9783031619038 Law for Professionals, 2662-1428 80922 https://doi.org/10.1007/978-3-031-61901-4 ZDB-2-LCR ZDB-2-SXLC 61994 61994