美国仿制药审评审批制度的经验分析与研究  

Review & approval process of generic drugs in US

作　　者：雷继峰 杨建红[2] 

机构地区：[1]上海安必生制药技术有限公司,上海200233 [2]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2016年第19期2240-2249,共10页Chinese Journal of New Drugs

摘　　要：20世纪80年代以来,美国为仿制药立法并系统建立了仿制药的管理制度,仿制药产业得到规范和发展,经过FDA审批的仿制药与原研药治疗等效从而在临床上大量替代价格昂贵的原研药,为美国政府、雇主和患者节省了大量医药费用。30年来,仿制药审评审批制度随着科学认识提高不断完善。本文从稳定的基本制度框架、连贯的审评程序和系统的技术标准3个层面,全面系统地介绍美国仿制药审评审批制度的经验,为我国仿制药审评审批制度改革提供参考。The generic drug industry in US has been well developed and regulated since the generic drug legislation was established in early 1980 s. The generic drugs approved by FDA are therapeutically equivalent and therefore interchangeable with the expensive brand-name drugs,which have saved a huge amount of money for the US government,employers,and patients. The systematic approach of generic drug review process has been adopted and improved by FDA with the increasing scientific understanding of pharmaceutical products and their manufacture process in the past three decades. This paper summarized the experience of the US generic drug regulation system from three aspects： stable framework of legislation, consistent review process, and comprehensive technical requirements,which may provide reference to CFDA in regard to the current reform initiatives on generic drug regulation in China.

关 键 词：仿制药 审评审批 治疗等效 生物等效 临床可替代 科学认知 FDA 

分 类 号：R95[医药卫生—药学]