美国药品审评正式争议解决程序评介及对我国的启示  

Formal dispute resolution of drug review in the United State and its implications for China

作　　者：耿晓雅 魏天颖 马坤[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2016年第18期2059-2066,共8页Chinese Journal of New Drugs

摘　　要：本文通过介绍美国药品审评正式争议解决程序(formal dispute resolution,FDR)的制度沿革和基本流程,分析该程序主要特点,并以2003—2014年药品评价和研究中心(Center for Drug Evaluation and Research,CDER)正式争议解决申请(formal dispute resolution request,FDRR)受理情况、绩效目标实现情况、认可率和用时等数据评价美国FDR程序实施效果,为完善我国药品审评争议解决机制提供参考。建议通过构建完善的法律体系、在技术审评阶段设置争议解决程序、注重与申请人沟通交流、建立复审专家委员会等措施完善我国药品审评争议解决机制。This paper summarizes the development history and current state of the formal dispute resolution procedure（ FDR） of United State,analyzes the major characteristics of it,and then evaluates the effect of FDR by using the statistical data of the acceptance,performance goals achievement,grant rate and time taken of FDRR in CDER from 2003 to 2014. On the base of that,this paper suggests to improve the FDR in China by building a sound legal system, setting up FDR procedure in technical review, and enhancing communication with the applicant.

关 键 词：药品审评 争议解决 美国 逐级申诉 咨询委员会 

分 类 号：R95[医药卫生—药学]