中国制药企业原料药出口的国际认证  

International registration of API for Chinese pharmaceutical company

作　　者：冯煜 权秀丽 崔洋 

机构地区：[1]步长集团生产运营管理中心,陕西西安710075

出　　处：《中国医药导报》2011年第23期111-113,144,共4页China Medical Herald

摘　　要：本文具体详实地描述了中国制药企业原料药出口欧洲和美国等发达市场时药品注册所应具备的基本条件,明确地描述了药物原料药注册时申请FDA认证,欧盟EDMF申请/COS证书认证所需要的文件、文件的格式以及认证的详细程序等,并且对未来全球范围内在ICH指南的前提下统一和规范药品注册所使用的CTD格式文件作了明确的说明,目的在于使中国原料药出口企业对于国际认证的现状和未来有所了解,明确认识国际注册认证程序和所需要的文件,生产工厂所应具备的基本条件等,并能对加快我国原料药的出口起到一定的促进作用。The article clearly describes the basic drug registration requirements for Chinese pharmaceutical company who exported APIs to US and European countries, and other developed markets, the registration dossier＇s format, especially the procedures for FDA approval and getting EDMF/COS certificate were also introduced in detail, and the CTD format under ICH guideline which was used in unitying and regulating the drug registration were also explained definitely. The purpose was to make Chinese local pharmaceutical company to understand the international authentication of the present and future and know the authentication procedures international registration files needed clearly and the basic conditions of the production factory and so on, and be a certain role in pushing the speed in the export of the API.

关 键 词：原料药:药物注册 FDA认证 DMF EDMF COS认证 

分 类 号：TQ460.4[化学工程—制药化工]