邀请人：

清华大学医学院  王钊  教授  (72240)

清华大学化学系  巨勇  教授  (92795)   
 

Abstract

This presentation will assess the current status of botanical new drug development, from the regulatory prospective of U.S. FDA.  Regulatory environment for botanical drugs in the U.S. will be reviewed first with summary of the FDA Botanical Guidance.  Recent regulatory experiences will then be described with analyses of investigational botanical drug submissions to the therapeutic divisions in FDA’s Center for Drug Evaluation and Research (CDER).  Since 1982, more than 300 botanical-drug pre-INDs and INDs have been submitted to the CDER, with a great majority received after the passage of Dietary Supplement Health Education Act (DSHEA) in 1994 and the drafting of CDER Botanical Guidance beginning in1995.  Further acceleration of the pace was seen since the release of draft Guidance for public comments in 2000 and the final version in June of 2004.  After these recent years of development efforts, the first New Drug Application (NDA) for a botanical drug product was approved by FDA in October 2006.  Regulatory and scientific problems encountered in our reviews of these applications will be discussed, with emphasis placed on the issues of clinical development, especially the late phase studies, of botanical new drugs.  The data suggest that, while the overall progress has been slow, there is a continuing and steady interest in further development of botanical new drugs and the first botanical NDA demonstrated the feasibility of the new regulatory approach. 

Biography of Shaw T. CHEN　（M.D., Ph.D.）

Dr. Chen was received his Ph.D. in Chemistry from Johns Hopkins, M.D. from University of Miami, pediatric residency training from University of Minnesota and a clinical/research fellowship from National Institutes of Health.  He is currently Associate Director, Office of Drug Evaluation I, Center for Drug Evaluation and Research (CDER), FDA, and Leader of the Botanical Review Team.  Dr. Chen is responsible for establishing and directing a new review system for botanical drug applications at CDER.  Prior to that, he was a Medical Team Leader at FDA’s Division of Cardiorenal Drug Products.  Dr. Chen has more than 18 years of extensive experiences in regulations of new drug development, clinical trial design & analysis, risk/benefit assessment in drug reviews, post-marketing safety surveillance and general regulatory affairs.  He is also a member of the FDA Botanical Working Group, responsible for drafting the new Guidance for botanical new drug development.