000 04119nam a22006255i 4500
001 978-3-031-61901-4
003 DE-He213
005 20251030112655.0
007 cr nn 008mamaa
008 240728s2024 sz | s |||| 0|eng d
020 _a9783031619014
_9978-3-031-61901-4
024 7 _a10.1007/978-3-031-61901-4
_2doi
050 4 _aK7000-7720.22
072 7 _aLB
_2bicssc
072 7 _aLAM
_2bicssc
072 7 _aLAW051000
_2bisacsh
072 7 _aLB
_2thema
072 7 _aLAM
_2thema
100 1 _aBalzano, John C.
_eauthor.
_4aut
_4http://id.loc.gov/vocabulary/relators/aut
_981442
245 1 0 _aChina Food and Drug Law
_h[electronic resource] :
_bPolicy, Practice, and Future Directions /
_cby John C. Balzano.
250 _a1st ed. 2024.
264 1 _aCham :
_bSpringer International Publishing :
_bImprint: Springer,
_c2024.
300 _aXVI, 389 p.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
490 1 _aLaw for Professionals,
_x2662-1428
505 0 _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.
520 _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.
650 0 _aPrivate international law.
_965660
650 0 _aConflict of laws.
_965661
650 0 _aInternational law.
_958292
650 0 _aComparative law.
_965662
650 0 _aAdministrative law.
650 0 _aFood
_xSafety measures.
_961309
650 0 _aAsia
_xPolitics and government.
_969658
650 1 4 _aPrivate International Law, International and Foreign Law, Comparative Law.
_965667
650 2 4 _aAdministrative Law.
650 2 4 _aFood Safety.
_967660
650 2 4 _aAsian Politics.
_969661
710 2 _aSpringerLink (Online service)
773 0 _tSpringer Nature eBook
776 0 8 _iPrinted edition:
_z9783031619007
776 0 8 _iPrinted edition:
_z9783031619021
776 0 8 _iPrinted edition:
_z9783031619038
830 0 _aLaw for Professionals,
_x2662-1428
_980922
856 4 0 _uhttps://doi.org/10.1007/978-3-031-61901-4
912 _aZDB-2-LCR
912 _aZDB-2-SXLC
999 _c61994
_d61994