欧盟仿制药参比制剂介绍  

The introduction of the reference medicinal products for marketing authorisation application of generic medicinal products in the EU

作　　者：许鸣镝[1] 牛剑钊[1] 杨东升 李涛[1] 乔利涛 高恬恬 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2017年第24期2933-2936,共4页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项资助项目(2015ZX09303001)

摘　　要：参比制剂的选择是药品仿制研究的一个重要环节。国家食品药品监督管理总局相关公告明确了用于仿制药质量与疗效一致性评价或仿制药申请时的参比制剂应为原研药品或国际公认的同种药物。为了方便我国仿制药企业合理选择和确定参比制剂,本文详细介绍了欧盟药品的4种审评方式:集中审评程序、非集中审评程序、互认审评程序和成员国独立审评程序,以及欧盟仿制药上市申请时参比制剂选择的方法和过程,包括联盟注册目录、互认审评程序产品目录以及欧盟成员国产品目录。It is vital to choose the right reference medicinal products during the research ＆ development of generic medicinal products. It is clearly specified in the relevant documents issued by the China Food and Drug Administration （CFDA） that the reference medicinal products used for the re-evaluation of generic medicinal products or the application for generic medicinal products should be innovative products or internationally recognized medicinal products of the same class. To facilitate the Chinese pharmaceutical enterprises choose and identify the reference medicinal products, detailed descriptions of the four medicinal product evaluation procedures, i.e., centralized procedure （CP）, decentralised procedure （DCP）, mutual recognized procedure （MRP） and national authorization procedure （NP）, are provided in this article as well as the methods and procedures, including the community register, MRI product index and approved drug products list of each member state of the European Union （EU） , for identifying the reference medicinal products used in the generic medicinal product application in the EU.

关 键 词：仿制药一致性评价 参比制剂 欧洲药品管理局(EMA) 集中审评程序 联盟注册目录 

分 类 号：R95[医药卫生—药学]