浅析中国药物临床试验管理规范与国际通用准则的异同点

Brief analysis the difference on the good clinical practice in ICH and China

依据中国2003年颁布实施的药物临床试验质量管理规范(GCP)与人用药品注册技术要求国际协调会议(ICH)GCP的相关内容,本文将中国GCP各章节内容与ICH GCP进行比较,分析两者间存在的异同点,以期为推动中国GCP制度的改革与发展提供参考。

According to the apprehension of good clinical practice （GCP） issued by China in 2003 and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use （ICH） GCP. The author compares each chapter of Chinese GCP with ICH GCP and discusses the similarities and differences between them to expect to impel the development and innovation of Chinese GCP＇s institution.