for high ones. There were polemics over whether a biosimilar approved in more than one indi-cation would require comparative trials in each of those indications. There were distracting discussions on a phenomenon known as drift, wherein the manufacturing processes for a biologic and its biosimilar ...
第一部分：Overview概述，在该模块可查询药物整个生命周期中各阶段的法规/指南，如：Advanced therapies 先进的治疗方法、Biosimilar medicines生物仿制药、Compliance法规、Data on medicines (ISO IDMP standards) 药品数据（ISO IDMP标准）、Fees付费信息、Medical devices医疗器械、Orphan designation孤儿药、Paediatric medi...
New EMA guidelines on biosimilar medicines
电话：+44(0)20 3660 6000 传真：+44(0)20 3660 5555 通过我们网址发送问题www.ema.europa.eu/contact 欧盟机构 ©2015年欧洲药物管理局版权所有。允许复制本文件，但必须声明本文件的来源。 2014年10月23日 CHMP/437/04 Rev 1 人用药品委员会(CHMP) 生物仿制药品指导原则 该指导原则替代生物仿制物药品...
第一部分:Overview概述,在该模块可查询药物整个生命周期中各阶段的法规/指南,如:Advanced therapies 先进的治疗方法、Biosimilar medicines生物仿制药、Compliance法规、Data on medicines (ISO IDMP standards) 药品数据(ISO IDMP标准)、Fees付费信息、Medical devices医疗器械、Orphan designation孤儿药、Paediatric medicines...
2)Medicine type药品类型搜索,包括:Accelerated assessment加速审评(可查询共112个药品的加速审评情况)、Additional monitoring附加监测(共766个药品需要完善相关信息)、Biosimilar生物仿制药(共101个药品)、Conditional approval有条件批准(共125种药品)、Exceptional circumstances特殊情况、Generic仿制药(共355中药品)、Orphan...
21 February 2013 Date for coming into effect 01 September 2013 Keywords Follicle stimulating hormone (FSH), similar biological products, comparability, non-clinical studies, clinical studies 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom An agency of the European Union ...
在该模块有药物整个生命周期中,各阶段法规/指南主题链接,如:Advanced therapies 先进疗法、Accelerated assessment加速审评、Biosimilar medicines生物类似药、Compliance法规、Fees付费信息、Product information产品信息、Scientific guidelines科学指南等等,各模块链接如下图所示: ...
在该模块有药物整个生命周期中,各阶段法规/指南主题链接,如:Advanced therapies 先进疗法、Accelerated assessment加速审评、Biosimilar medicines生物类似药、Compliance法规、Fees付费信息、Product information产品信息、Scientific guidelines科学指南等等,各模块链接如下图所示: 点击其中的 Compliance法规 链接,可查询产品生命周...