Traditional Chinese Medicine Project

　　　 Since 2001, CDE has been commissioned for the Committee on Chinese Medicine and Pharmacy (CCMP), DOH, to review the clinical trial protocol for traditional Chinese medicine (TCM), including herbal remedies.

　　　CDE also has been commissioned by the CCMP to draft/revise related guidelines by consulting with the related management stipulations of the Europe and the U.S., and considering the current status of new drug R&D of TCM in this country as well. We have revised “The Guidance for New TCM Application”, and we have drafted “The TCM Trial Guideline in Osteoporosis Treatment”. Meantime, the joint CDE-CCMP team has carried out a simulating clinical inspection in order to enhance the implementation quality of TCM clinical trial.

　　　In addition, CDE has been keeping a clear communication channel with sponsors and R&D institutions by holding regularly the “Joint Industry-Academia Meeting” focused on the topics, such as “the R&D consideration of singular TCM selection and regulatory restrictions”, “how to evaluate and interpret the toxicology data generated in China”, and “how to verify the TCM human experience”, etc., which are the current concerns of the TCM industry. Through these active meetings, mutual interaction and effective communication are anticipated to be achieved.