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...
制剂成品生产指南 This guideline replaces the “Note for Guidance on Manufacture of the Finishe d Dosag e Form”(CPMP/QWP/486/95)原创：2017-09-19 翻译组 GMP办公室 翻译：王世华 校对：Owen Executive summary 综述 This guideline replaces the note for guidance on the manufacture of the finish...
The general guidance should be used to develop product-specific protocols to demonstrate equivalence, facilitated by obtaining scientific advice, as necessary. 关于安全性和局部耐受性的等效性可以从活性物质的知识和已完善的辅料的选择中推断岀来。针对简单配方,从渗透动力学或药效等效性研究中可获得生物等效豁免...
21 May 2015 EMA/CHMP/315234/2014 Committee for Medicinal Products for Human Use (CHMP) Tadalafil film-coated tablets 2.5, 5, 10 and 20 mg product-specific bioequivalence guidance* Draft agreed by Pharmacokinetics Working Party (PKWP) October 2013 Adoption by CHMP for release for consultation 24...
or used for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent for rinsing vessels, equipment, primary packaging materials, etc. 水是制药行业所用的主要公用系统之一。它可以作为辅料使用,亦可用于药品调配;可用于合成,亦可用于制剂生产, ...
the risk assessment, WFI may be required in some cases for manufacture of non-sterile vaccines where in order to ensure the vaccines’ safety and quality (avoiding introduction of microorganisms undesirable in the specific finished product formulation) greater microbiological purity of water is needed....
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...
For transportation of bulk product (intermediate) between manufacturing sites guidance is given in GMP Annex 15 on how transport should be taken into co nsideration. The impact of short or longer excursions outside of the original st orage conditions should be discussed, where necessary, supported...