Approaching China's Pharmaceutical Market A Fundamental Guide to Clinical Drug Development /

• Corporate Author: SpringerLink (Online service)
• Other Authors: Lu, Ming Q. (Editor)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2015.
• Subjects: Medicine.; Pharmaceutical technology.; Biomedicine.; Pharmaceutical Sciences/Technology.

This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strat...

Table of Contents:

• 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.