日本新药审评绩效考核方案及其对中国的借鉴

Performance appraisal system of new drug review in Japan and its reference to China

近年来,药品注册审评效率问题在"医改"中备受瞩目,审评绩效考核是未来发展的必然趋势。本文通过分析归纳日本的新药审评制度及其绩效考核方案的特点,指出我国新药审评绩效考核方面的可借鉴之处在于加强审评机构的自检工作、突出对新药审评时限的考核以及加强信息公开、提升外部监督作用。

In recent years,the efficiency of drug registration and evaluation has attracted much attention in the healthcare reform.And performance appraisal is an obvious tendency of future development for drug review.This paper analyzed the characteristics of Japanese drug review system and performance appraisal program,pointed out that China＇s drug review performance appraisal should strengthen the self-inspection work,highlight the evaluation of drug review time,and strengthen information disclosure to improve the external supervision function.