ICH-GCP基本原则分析与启示

Analysis and inspiration of the basic principles of ICH-GCP

ICH-GCP是药品国际注册中共认的GCP。ICH-GCP列出的13条基本原则是GCP的科学性和伦理性原则的集中体现,是ICH-GCP的精华所在。随着我国药品审评审批制度改革的深入推进,我国GCP与ICH-GCP全面接轨已经是大势所趋。本文对ICH-GCP的13条基本原则进行全面解析,以期从中得到对我国GCP发展与临床试验实践有益的启示。

ICH-GCP is the recognized commonly GCP in drug international registration.The 13 basic principles of ICH-GCP epitomize the scientific and ethic nature of GCP and are the essence of ICH-GCP.With the deepening of the reform of drug registration system,that totally connecting China’s GCP with ICH-GCP is the general trend of development.The purpose of this study are to systematic analyze the 13 basic principles of ICH-GCP,and to get the inspiration for the improvement of China’s GCP and clinical trail practice.