LEADER 04163nam 22006975 450 001 9910878043903321 005 20250807132227.0 010 $a9783031619014$b(electronic bk.) 010 $z9783031619007 024 7 $a10.1007/978-3-031-61901-4 035 $a(MiAaPQ)EBC31570051 035 $a(Au-PeEL)EBL31570051 035 $a(CKB)33469064500041 035 $a(DE-He213)978-3-031-61901-4 035 $a(OCoLC)1450897497 035 $a(EXLCZ)9933469064500041 100 $a20240728d2024 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aChina Food and Drug Law $ePolicy, Practice, and Future Directions /$fby John C. Balzano 205 $a1st ed. 2024. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2024. 215 $a1 online resource (399 pages) 225 1 $aLaw for Professionals,$x2662-1428 311 08$aPrint version: Balzano, John C. China Food and Drug Law Cham : Springer International Publishing AG,c2024 9783031619007 327 $a1. 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. 330 $aThis book is an analysis of policy and law governing the development, approval, manufacture, distribution, marketing and post-market surveillance of human drugs, medical devices, foods and cosmetics in Mainland China (?China FDD Regulation?). It analyzes the policy and general principles behind China FDD Regulation, including the history and jurisdiction of the central and local agencies that administer the laws and regulations, the administrative law structure in which these agencies operate, and other aspects of FDD Regulation interpretation and enforcement. Although it describes practice in China, this book is written in the comparative perspective (i.e., sensitive to assumptions made by those who are steeped in FDD Regulation in the U.S., Japan, and the EU). It includes one chapter on each regulatory space (drugs, medical devices, cosmetics, and food) organized by the lifecycle of products. It also covers subcategories of products, such as vaccines, radiopharmaceuticals, and in vitro diagnostic medical devices. The book includes specialty chapters on areas that are common to multiple types of regulated products, such as biosecurity and advertising. It is the first English language book of its kind, and it can serve as a resource for those in the FDD law and regulatory field to understand the mechanics of developing and marketing products, but also with insights for businesspeople and others, who are developing China-strategies. 410 0$aLaw for Professionals,$x2662-1428 606 $aConflict of laws 606 $aConflict of laws 606 $aInternational law 606 $aComparative law 606 $aAdministrative law 606 $aFood$xSafety measures 606 $aAsia$xPolitics and government 606 $aPrivate International Law, International and Foreign Law, Comparative Law 606 $aAdministrative Law 606 $aFood Safety 606 $aAsian Politics 615 0$aConflict of laws. 615 0$aConflict of laws. 615 0$aInternational law. 615 0$aComparative law. 615 0$aAdministrative law. 615 0$aFood$xSafety measures. 615 0$aAsia$xPolitics and government. 615 14$aPrivate International Law, International and Foreign Law, Comparative Law. 615 24$aAdministrative Law. 615 24$aFood Safety. 615 24$aAsian Politics. 676 $a340.9 700 $aBalzano$b John C$01753295 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 912 $a9910878043903321 996 $aChina Food and Drug Law$94189141 997 $aUNINA