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...
一旦被欧盟委员会批准,集中上市许可在所有欧盟(EU)成员国、冰岛、挪威和列支敦士登有效。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...
一旦被欧盟委员会批准,集中上市许可在所有欧盟(EU)成员国、冰岛、挪威和列支敦士登有效。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...
The guidance, prepared by the agency's SmPC Advisory Group, consists of a set of presentations detailing the information that should be included in each of the sections of the SmPC, together with a presentation and video providing background information on SmPCs. It is intended to enable ...
guidance to applicants EMA/CHMP/SAWP/72894/2008 Rev.1 Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection EMA/CHMP446337/2011 Reflection paper on pharmacogenomis in oncology EMEA/CHMP/PGxWP/128435/2006...
NMPA. Notifications of the 5 guidances issued by the CDE, NMPA on the research and development for COVID-19 preventive vaccines (trial implementation) (No.21 of 2020) [EB/OL]. (2020-08-14) [2021-04-06]. https://www. nmpa. gov.cn/yaopin/ypggtg/20200814230916157.html. [4] EMA. ...
The guidance provides that EU Member States may, in their territory, accept medicinal products in relation to which the SMPC and patient information leaflet have not yet been translated into the official national language. The competent national authorities may also accept packaging and labeling that ...
SmPC 是医疗专业人员如何安全有效地使用药 品的信息基础.包装说明书(Package Leaflet,PL) 应根据 SmPC 编写.人用药品标签和包装说明书中 的辅料指导原则[4]也适用于 SmPC. 对特定医疗状态的治疗 ,SmPC 不提供一般性 建议.相反 ,应提及与使用药物或其效果有关的治 疗的具体方面.同样 ,不应包括对给药方法的...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/principles-codevelopment-in-vitro-companion-diagnostic-device-therapeutic-product (2016) Google Scholar 19 European Medicines Agency Regulation (EU) 2017/746 of the European parliament and of the council of 5 April 2017 on in ...
(CPMP/EWP/2339/02) Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function (CHMP/EWP/225/02) A guideline on summary of product characteristics (SmPC) September 2009(Eudralex vol 2C) Guideline on reporting the results of ...