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...
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。
The product team is available to address any questions MAHs may have regarding a particular upcoming post-authorisation applications. Where appropriate, a pre-submission meeting could be organised at the Agency in order to obtain further procedural and regulatory/legal advice. This guidance information...
2.4. Otherguidance其它指南 Action: Lead(职责:领导) Q&As on the implementation of theupdated shared facilities guidance更新后的共用设施指南实施问答 3. Medicinal Product-specific activities药品特定活动 3.1. Pre-Authorisationactivities批准前活动 •Contribution...
This must be assessed in each individual case verifying that the requirements of appropriate Notes for Guidance are met. The authorisation of the parametric release programme will be granted on the basis of an assessment of how well the manufacturing process concerned is founded. The demonstration ...
5、 regulation in the field of nanodrugs besides,a series of specifications and related guidelines have been promulgated to ensure the safety of nanodrugs by contrast,research and development of nanodrugs started late in our country,and supervision and guidance on the safety evaluation principle are ...
An update or change of a stand-alone ASMF is not foreseen and can only beaddressed in connection with a marketing authorisation. The type of thevariation(s) is dependent on the type of the single changes introduced in theupdated version. The update – including changes to the open and /or...