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...
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 ...
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...
Specific guidance isprovided: 本指南适用于应用于局部皮肤并发挥局部作用药物,也适用于其他药物,例如眼用药物与耳用药物。具体内容包括:On the quality of topical products not covered by otherguidelines. 其他指南未涵盖的外用制剂的质量。 On equivalence testing of topical products in lieu of therapeutic ...
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. ...
(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 ...
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...
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...