英国药品和医疗保健产品管理局的绩效考核及其对中国药品审评的借鉴  

Performance evaluation of the UK Medicines and Healthcare Products Regulatory Agency and its reference to Chinese drug reviews

作　　者：陆倩妮 席晓宇[1] 褚淑贞[1] 

机构地区：[1]中国药科大学,南京211198

出　　处：《中国新药杂志》2017年第21期2497-2501,共5页Chinese Journal of New Drugs

基　　金：2015年度教育部人文社科青年基金项目(15YJC790116);2016年度中国药科大学中央高校基本科研业务费配套项目(2016PTW03);2016年度中国药科大学国际医药商学院力凡胶囊科研基金资助(CPUSIPB-201610)

摘　　要：英国药品和医疗保健用品管理局(Medicines and Healthcare Products Agency,MHRA)主要负责英国药品审评与监管等多项与药品和医疗保健用品有关的工作,多年来采用一套特殊的绩效考核方案,对该部门员工的8大类考核领域进行22项指标的评估与考核,使整体机构有序、科学地运营。本文在介绍该绩效考核方案的同时,分析该方案的合理之处,并以此为基础提出对我国药品审评监管的借鉴意义,以期建立我国药品审评机构的绩效考核体系,提升我国药品审评机构形象,进而间接提升药品审评效率。UK Medicines and Healthcare Products Regulatory Agency（ MHRA） is an agency mainly responsible for the British drug review and supervision,and other drugs and healthcare products related works. Its special performance assessment system,which consists of eight assessing fields and twenty-two indexes,has helped MHRA working scientifically and operating in good order for years. So,the purpose of introducing this performance assessment,as well as to analyze its advantages is to set up our own performance assessment system on this basis.It can help us to improve the image of Chinas drug review institution,and also,to promote the efficiency of drugs reviews.

关 键 词：英国药品和医疗保健产品管理局 绩效考核 药品审评 

分 类 号：R95[医药卫生—药学]