药物创新审评机制的分析与改进建议  

Analysis of Medicine Innovation Appraisal Mechanism and Improvement Suggestions

作　　者：白锦表[1] 

机构地区：[1]浙江医药高等专科学校,浙江宁波315100

出　　处：《中国药房》2013年第21期1930-1932,共3页China Pharmacy

摘　　要：目的:为改进新药审评机制,促进我国药物创新提供参考。方法:结合我国"新医改"政策,分析我国药物创新审评机制现状及国外鼓励药物创新的审评机制,并提出改进我国新药审评机制的建议。结果与结论:我国现行的《药品注册管理办法》法律地位仍显薄弱,未能有效实现对药品上市前注册机制的制度设计,4次修订期间因条款修改及解决一系列次生问题而发布的补充通知和文件较多,使得政策丧失了严肃性和连续性。国外采用多种优先审评模式以加快新药审评,比较典型的有美国FDA的特殊程序和欧盟药品管理局(EMA)的加速审评程序。建议政府完善药品注册与审评机制,移植或改进现有的次级制度;协调与国际创新活动的交流与合作;参考国际标准以提高国内新药研发服务能力。OBJECTIVE：To provide reference for the promotion of new medicine appraisal mechanism and medicine innovation in China.METHODS：Based on ＂New Medical Reform＂ in China,suggestions were put forward to improve appraisal mechanism of new medicine in China by analyzing the situation of new medicine innovation appraisal mechanism in China and appraisal mechanism of encouraging new medicine innovation in foreign countries.RESULTS CONCLUSIONS：The legal status of Drug Registration Management Approach in China is not given sufficient emphasis,and there is no system designed for medicine registration before listing;many notices and documents have been issued because of item revision and a series of secondary problems occured during 4 times of revision periods;the policies lack seriousness and continuity.Multiple appraisal priority models are adopted abroad to improve new medicine appraisal,such as typical model,i.e.FDA special procedure and EMA accelerated appraisal procedure.It is proposed that the government should consummate the medicine registration and appraisal mechanism,transplant or improve current secondary system,coordinate the exchanges and cooperation with the international counterparts in terms of innovation as well as observing the international criteria so as to improve the domestic capacity of RD and relevant services.

关 键 词：新医改 药物创新 注册 审评 机制 

分 类 号：R954[医药卫生—药学]