OECD“GLP原则”与中国“GLP规范”的比较

Comparison Study on Principles of Good Laboratory Practice for Non-clinical Studies of Drugs Issued by OECD and SFDA

OECD“GLP原则”是西方工业国家共同遵循的GLP规范。为便于国内与国外在新药研发方面的合作与交流,将国家食品药品监督管理局(SFDA)最新公布的“GLP规范”同OECD“GLP原则”作一比较。两份GLP规范整体结构和涵盖的内容基本一致,特别在有关实验设施及仪器管理、标准操作规程(SOP)、档案管理等方面几乎完全相同;但在人员职责、试验方案及总结报告审批等方面有些差异。

The ＂Good Laboratory Practice for Non-clinical Studies of Drugs＂ issued by SFDA was compared in principles with that of OECD which was generally followed in western industrial countries. Purpose of the comparison is for good cooperation and exchange in new drug research and development between China and other countries. It was concluded that the GLP issued by SFDA and OECD were basically consistent in general structure and topics, and nearly completely the same in the aspect of lab facility and equipment management, SOP and documentation control, but with regard to personal responsibility, tes： ring protocol and approval of final report, some diffrences are existed.