美国首仿药制度介绍及对我国的启示  

Introduction of the First Generic Drug System in the United States and Its Enlightenment to China

作　　者：张洁铭 罗时珍 刘毅俊 彭安林 毛宗福 ZHANG Jieming;LUO Shizhen;LIU Yijun;PENG Anlin;MAO Zongfu(School of Health Sciences,Wuhan University,Wuhan 430071,China;Health and Family Planning Commission of Wuhan Municipality,Wuhan 430014,China;The Affiliated Tongren Hospital of Wuhan University/Wuhan Third Hospital,Wuhan 430060,China)

机构地区：[1]武汉大学健康学院,武汉430071 [2]武汉市卫生和计划生育委员会,武汉430014 [3]武汉大学附属同仁医院/武汉市第三医院,武汉430060

出　　处：《中国药房》2018年第22期3025-3028,共4页China Pharmacy

基　　金：中国科协高端科技创新智库青年项目(No.DXBZKQN-2017-040);教育部人文社会科学研究青年基金项目(No.17YJC630220)

摘　　要：目的:为促进我国首仿药的发展提供参考。方法:采用文献研究的方法,介绍美国首仿药相关配套制度,结合我国首仿药的发展现状和有关制度,指出我国首仿药制度中存在的问题,并给出完善建议。结果:美国首仿药制度包括首仿药市场独占制度、橙皮书制度、简明新药申请制度、首仿药临床试验数据保护制度、首仿药药品专利链接制度和仿制药替代制度等一系列有关首仿药研发、注册、审批、采购等环节的政策和法律法规及其完整的配套制度,这些制度均加快了其首仿药的流通和使用。而我国目前仅在首仿药的定价、注册、审批方面有部分零散规定,尚缺乏完整的首仿药配套制度。结论:我国可借鉴美国成熟的首仿药制度,明确首仿药的定义,简化首仿药的注册审批,建立首仿药的数据保护制度,并从招标采购和医保层面保障首仿药的流通使用,从而促进我国首仿药的发展。OBJECTIVE:To provide reference and suggestion for the development of the first generic drugs in China.METHODS:By the method of literature study,related system and regulations of the first generic drugs in the United States were introduced;according to the development and related systems of the first generic drugs in China,the problems about first generic drug system in China were pointed out.The improvement suggestions were put forward.RESULTS:In the United States,first generic drug system included a series of policies,legal system and complete supporting systems about R&D,registration,approval and purchase of first generic drugs,such as market exclusive system,orange book system,abbreviated new drug application system,first generic drug clinical trial data protection system,drug patent link system,and medical insurance generic drug replacement system;it sped up the distribution and application of the first generic drugs.At present,there were some policies and regulations about pricing,registration and approval;but there was no complete supporting system of the first generic drugs.CONCLUSIONS:The development of the first generic drugs can be promoted in China by referring to relatedmature supporting system of the first generic drugs in the United States,clarifying the definition of the first generic drugs,simplifying registration and approval procedure of the first generic drugs,establishing data protection system of the first generic drugs and guaranteeing the distribution and application of the first generic drugs from the biading and aspect of medical insurance.

关 键 词：美国 首仿药 制度 启示 

分 类 号：R951[医药卫生—药学]