包括：Obtaining an EU marketing authorisation获得欧盟的上市许可, The evaluation of medicines step-by-step逐步获得欧盟市场许可、Pre-authorisation guidance授权前相关指南、Fees缴费、Product information产品信息、Pharmacovigilance药物警戒和Compliance法规。Eudralex 第1卷 ：人用医药产品的药品法规，在这里可以查询EC颁...
包括:Obtaining an EU marketing authorisation获得欧盟的上市许可, The evaluation of medicines step-by-step逐步获得欧盟市场许可、Pre-authorisation guidance授权前相关指南、Fees缴费、Product information产品信息、Pharmacovigilance药物警戒和Compliance法规。 Eudralex 第1卷 :人用医药产品的药品法规,在这里可以查询EC颁...
包括:Obtaining an EU marketing authorisation获得欧盟的上市许可, The evaluation of medicines step-by-step逐步获得欧盟市场许可、Pre-authorisation guidance授权前相关指南、Fees缴费、Product information产品信息、Pharmacovigilance药物警戒和Compliance法规。 Eudralex 第1卷 :人用医药产品的药品法规,在这里可以查询EC颁...
3.2.3 Marketing authorisation 上市授权 对通过欧盟集中审评的相关要求,包括:Obtaining an EU marketing authorisation, step-by-step逐步获得欧盟市场许可、Pre-authorisation guidance授权前相关指南、Fees缴费、Product information产品信息、Pharmacovigilance药物警戒、Compliance法规等。 3.2.4 Post-authorisation 授权后管理...
FDA Guidance Documents:可查询指南性文件,如指导原则、法规等; Recalls, Market Withdrawals and Safety Alerts:可查询产品的召回、撤市和安全警报等情况; Press Announcements:发布的新闻公告; Warning Letters:可查询FDA开出的警告信; Advisory Co...
对通过欧盟集中审评的相关要求,包括:Obtaining an EU marketing authorisation, step-by-step逐步获得欧盟市场许可、Pre-authorisation guidance授权前相关指南、Fees缴费、Product information产品信息、Pharmacovigilance药物警戒、Compliance法规等。 3.2.4 Post-authorisation 授权后管理 ...
For additional guidance on changes to existing presentation that cantrigger new EU number(s) please see theEMA post-authorisation guidance for Type IA, Type IB and Type II variations. 可能会激活新EU编号的现有形式变更更多指南参见上述网址。
For additional guidance on changes to existing presentation that cantrigger new EU number(s) please see the EMA post-authorisation guidance for Type IA, Type IB and Type II variations. 可能会激活新EU编号的现有形式变更更多指南参见上述网址。 2.7. How should I submit a new working cell bank(WCB...
Please refer to the individual question & answers as published in the post-authorisation guidance for access to the hyperlinked information. Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with the relevant date upon publication. This guidance document...
? Email a friend Help This guidance addresses a number of questions which Marketing Authorisation Holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency's position on issues, which are typically addressed in discussions or meetings with MAHs in the Post-...