关于中医特色GCP的思考

我国《药品临床试验管理规范》（ＧＣＰ）的颁布施行，将对于中药临床试验循着科学化、规范化方向发展起到巨大的推动作用。同时也是新形势对中医药发展提出的新要求。努力探索一套既体现中医药特色，又与国际标准接轨的ＧＣＰ规范操作系统，构筑规范的中医证候诊断标准和临床结局评估标准，不仅是中医药现代化发展的需要，也是对现行ＧＣＰ的一种有益的补充。

Challenge,Chance and Ponderation on GCP with Features of TCM

The promulgation and implement of good clinical practice (GCP) in China has been playing an important role in developing clinical trials of traditional Chinese medicine (TCM) towed scienctific and standand direction. Meanwhile, a new demand for the development of TIM under the new situation has been put forward. Therefore, striving to search a series set of standard operating system for GCP and to establish canonical standard of diagnosis and clinical ending assessment of TCM, with the features of TCM and in line with international standard, is not only the requirement to develope TCM modernization, but also a helpful supplement for going GCP.