EMA对化学原料药生产起始物料的选择和论证要求思考.pdf

EMA 对化学原料药生产起始物料的选择和论证要求思考 EUROPEAN MEDICINES AGENCY SCIENCE MEDICINES HEALTH 16 September 2014 EMA/448443/2014 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances 化学原料药生产起始物料的选择和论证要求思考 Agreed by CHMP/CVMP Quality working party 11 July 2014 Adoption by CHMP September 2014 Adoption by CVMP September 2014 Keywords Starting material, active substance. 关键词 起始物料、活性物质 Introduction: 概述 This reflection paper aims to clarify some of the expectations of EU competent authorities arising from the guidance found in ICH Q11 (Development and Manufacture of Drug 1 Substances (Chemical Entities and Biotechnological/Biological Entities) regarding the information to be submitted in marketing authorisation dossiers to justify the selection of starting materials. Whilst ICH Q11 is not generally applicable to veterinary products, the principles outlined in this document should apply equally for active substances destined to treat both humans and animals. The document re-produces extracts from section 5 of ICH Q11 verbatim in black text, and provides subsequent commentary on EU expectations in the form of explanatory notes within grey-shaded boxes. 本思考文章目的是澄清由ICH Q11 指南（原料药研发和生产（化学实体和生物技术/生物制 品实体））引出的，关于上市许可文件提交的用于论述起始物料选择的资料中，欧盟药监机 构的态度。尽管ICH Q11 并没有普遍应用于兽药产品，在本文中列出的原则还是同样适用 于人兽共用活性物质。文件中摘要的ICH Q11 第5 部分内容以黑体字表示，相应的欧盟态 度的解说以注释形式放在灰色阴影方框中。 It should be recognised that this document is not intended as a