Reg.C229/03 EEC
Therefore generic applications referring to Community marketing authorisation dossier for medicinal products which are essentially similar to Community authorised products
(EC) No 726/2004 Article 3(3)：
A generic medicinal product of a reference medicinal product authorised by the Community
感觉后者适用 化药仿制药 ，也在学习
谢谢 也就是说含有similar的一般指代生物类似药，那就说的通了 一直做化药仿制药 没注意这个
另外，再请教一下，FDA化学仿制药在申报的时候，不需要完成工艺验证，工艺验证只需要在上市之前完成，国内申报的时候需要附上工艺验证报告，我的问题是，欧盟注册，at the time of submission，需要完成工艺验证吗？谢谢
查看EMA的指导原则
Annex I: Process validation scheme
Where validation data on production scale batches are not provided with the application and traditional process validation as described in section 5.1(Traditional process validation) is proposed, the process validation scheme described below should be submitted by the applicant.
Following completion of the scheme, a report containing the following information and signed by the appropriate authorised person should be generated and made available for inspection:
字面意思：如果有把握的话，可以在注册申请时提交工艺验证框架，在现场检查时提供工艺验证报告。
欧洲申报时是否需要工艺验证，可分情况对待：有standard和non-standard工艺之分，如果是non-standard的工艺，如缓控释、无菌制剂等风险比较高的，需要在申报前完成工艺验证，并且申报；如果是传统工艺，则可以暂时在申报前不做工艺验证，但是需要有工艺验证方案。EMEA发布的制剂工艺验证指南中有更加详细的说明。Guideline on process validation for finished products - information and data to be provided in regulatory submission
谢谢 我的理解也一样，(EC) No 726/2004 Article 3(3)，明确仿制药可以申请集中审批程序也可申请成员国审批程序，但查阅C 229/03 EEC 条令”Therefore generic applications referring to Community marketing authorisation dossier for medicinal products which are essentially similar to Community authorised products falling under the scope of Part B of the Annex to Regulation (EEC) No 2309/93, must follow the centralised procedure“，又感觉仿制药申报程序必须和参比制剂一致，所以凌乱了，第一次接触欧盟注册，法规上理解可能存在错误，请指教
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