Description
Approaching China's Pharmaceutical Market, Softcover reprint of the original 1st ed. 2015
A Fundamental Guide to Clinical Drug Development
Coordinator: Lu Ming Q.
Language: EnglishSubjects for Approaching China's Pharmaceutical Market:
Keywords
CFDA; FDA; drug management law; investigational drug; regulatory guidance
Publication date: 10-2016
Support: Print on demand
Publication date: 08-2015
648 p. · 15.5x23.5 cm · Hardback
Description
/li>Contents
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Preface.- Law, Regulation and Guidance.- Pharmaceutical Intellectual Property Rights in China.- The China Food and Drug Administration (CFDA).- Registration.- Guidance for Application Materials/Booklets (Chemical).- New Investigational Drug Application.- Clinical Development of Investigational New Drug.- Strategic Drug Development in China and Surrounding Countries.- Drug Safety Monitoring and Reporting Systems in China.- In Vitro Diagnostic Development.- Index.
Addresses the key issues for multinational pharmaceutical companies looking to market their drugs in China
Highlights the regulations of the Chinese State Food and Drug Administration (SFDA) and the Center for Drug Evaluation of the SFDA (CDE)
Serves as a fundamental guide for clinical research, regulatory, quality control/assurance, and legal departments
Includes supplementary material: sn.pub/extras
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