摘要
详细描述了中国制药企业原料药出口欧洲时药品注册所应具备的基本条件,明确说明了原料药申请EDMF文件/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,并且对药品注册所使用的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欧盟认证有所了解,明确认识欧盟注册认证的程序与所需的文件等。
This paper describes basic requirement which API exported to Europe should have,and clarifies the necessary documents used to apply COS certification,including its format,and the detail procedure of how to apply the COS certification. The paper also explain the CTD format document which used in drug registration.The paper aims to make a sense of EU certification to API exporting company,as well as the registration procedure and documents.
