03740nam a22005415i 4500001001800000003000900018005001700027007001500044008004100059020001800100024003500118050001800153072001500171072001600186072002300202072001400225072001500239100007800254245011700332250001800449264007500467300003400542336002600576337002600602338003600628347002400664490003800688505043300726520146401159650003102623650002202654650002302676650002102699650002402720650002702744650003502771650007902806650002402885650001702909650002002926710003402946773002602980776003603006776003603042776003603078830003803114856004603152978-3-031-61901-4DE-He21320251030112655.0cr nn 008mamaa240728s2024    sz |    s    |||| 0|eng d  a97830316190147 a10.1007/978-3-031-61901-42doi 4aK7000-7720.22 7aLB2bicssc 7aLAM2bicssc 7aLAW0510002bisacsh 7aLB2thema 7aLAM2thema1 aBalzano, John C.eauthor.4aut4http://id.loc.gov/vocabulary/relators/aut10aChina Food and Drug Lawh[electronic resource] :bPolicy, Practice, and Future Directions /cby John C. Balzano.  a1st ed. 2024. 1aCham :bSpringer International Publishing :bImprint: Springer,c2024.  aXVI, 389 p.bonline resource.  atextbtxt2rdacontent  acomputerbc2rdamedia  aonline resourcebcr2rdacarrier  atext filebPDF2rda1 aLaw for Professionals,x2662-14280 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.  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. 0aPrivate international law. 0aConflict of laws. 0aInternational law. 0aComparative law. 0aAdministrative law. 0aFoodxSafety measures. 0aAsiaxPolitics and government.14aPrivate International Law, International and Foreign Law, Comparative Law.24aAdministrative Law.24aFood Safety.24aAsian Politics.2 aSpringerLink (Online service)0 tSpringer Nature eBook08iPrinted edition:z978303161900708iPrinted edition:z978303161902108iPrinted edition:z9783031619038 0aLaw for Professionals,x2662-142840uhttps://doi.org/10.1007/978-3-031-61901-4