Approaching China's Pharmaceutical Market

Ming Q. Lu, M.D., Ph.D, is a senior medical director at Helsinn Therapeutics, Inc. He received his M.D in P.R. China and his Ph. D from the University of Connecticut, and completed a fellowship at Johns Hopkins Medical Schools under academician Peter Agre, M.D, who in 2003 received the Nobel Prize. Dr. Lu has expansive experience in both academia and pharmaceutical industry, particularly in research and development (R&D) of new medications. Since 1998, he has been heavily involved in the conduct and management of various aspects of clinical drug research and development, running the gamut from project initiation, to drug candidate discovery, and from pre-clinical pharmacology to all the clinical phases in both the US and overseas, especially in mainland China. He has also chaired the regulatory filing and defense processes with China Food and Drug Administration (CFDA), leading to the success of marketing approval in both China and Hong Kong.

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.