Advances in Biopharmaceutical Technology in China
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Chapter 8:   Regulatory Requirements Applicable to Clinical Trials in China

Ming Yu*, Janice Hou, and Ruoyu Li
MMD Pharmahe
5432 Connecticut Ave, Suite 501
Washington, DC 20015
Phone: 240-505-6259
Fax: 202-363-5444

About the Author:
Ming Yu
Dr. Ming Yu, Vice President of MMD Pharmahe Ltd., received her M.D. from Beijing Medical University (Peking University Medical Center, now) and Ph.D. from Georgetown University. She practiced internal medicine and occupational medicine in China and has been working on cancer research in the US. Ming Yu can be reached at:

Janice Hou
Janice Hou holds an MBA degree and is an expert in new drug registration and clinical trial management in China. She has more than 10 years' hospital working experience as well as extensive experience in product marketing and medical affairs management (Registration and Clinical Trials). Over the past 10 years, Ms Hou has held the positions of Public Relations Manager, Business Development Manager and Marketing director in multi-national and joint-venture pharmaceutical companies and has obtained license approval by the SFDA in China for 20 products.

Ruoyu Li
Dr. Ruoyu Li received her M.D. from Beijing Medical University. She is now a professor and the Chairmen of the Department of Dermatology of the First Hospital, Peking University. Dr. Li is also the vice director of the Research Center for Medical Mycology at Peking University and the President of the Society of Mycology of the Chinese Society of Microbiology and Medical Mycology as well as being the Director of the Asia Pacific Society of Medical Mycology. The Department of Dermatology, which Dr. Li chairs, is a clinical trial institute certified by the SFDA. During the last 10 years, Dr, Li has been instrumental in completing 15 trials.

Clinical trials must be conducted before a drug is registered in China. A clinical trial is an expensive and time-consuming process with a complex set of regulatory requirements to satisfy. In recent years, there has been notable improvement in the implementation of Chinese standards for ensuring the quality, safety, and efficacy of new drugs. This chapter introduces some of the basic regulations, technical guidelines and key characteristics of conducting clinical trials in China. Case studies have been provided to illustrate cost, time, and management considerations.

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Eric Langer
BioPlan Associates, Inc.
2275 Research Blvd, Suite 500
Rockville, MD 20850
Phone: 301-921-5979; Fax: 301-926-2455