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Beschreibung
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. Dieses Produkt haben wir gerade leider nicht auf Lager.
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Bis zu 50 % günstiger als neu
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Technische Daten
Erscheinungsdatum
28.07.2024
Sprache
Englisch
EAN
9783031619007
Herausgeber
Springer International Publishing
Serien- oder Bandtitel
Law for Professionals
Sonderedition
Nein
Autor
John C. Balzano
Seitenanzahl
389
Einbandart
Gebundene Ausgabe
Buch Untertitel
Policy, Practice, and Future Directions
Transparenz & Sicherheit
Hersteller: Springer, Europaplatz 3, Heidelberg, Deutschland, 69115, ProductSafety@springernature.com, Springer Nature Customer Service Center GmbH
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