上海EDMF编撰的培训资料.docVIP

Technical Requirements for the Registration Dossier of EDMF/COS/CTD and Filing strategies in EU countries EDMF/COS/CTD注册文件的技术要求及在欧盟国家的文件编撰策略 Technical Requirements技术要求 EDMF compilation in CTD format CTD格式的EDMF的编撰: a) Module 3.2. S. Drug Substance模块 3.2. S. 药物物质 b) Module 2.3 Quality Overall Summary模块 2.3 质量概述 CEP Procedure versus the DMF Procedure CEP程序对DMF程序 Filing strategies in EU countries在欧盟国家的文件编撰策略 Certification of suitability to the monographs of the European Pharmacopoeia针对欧洲药典专论的适应性证书 Procedure ,Submission of the Dossier, Content of the Dossier/Expert Report, Assessment, Timetable, Follow-up程序，文件递交，文件内容/专家报告，评估，时间表，后续工作 How to get the guideline from the Internet ? 如何从互联网得到指南? Human medicine or vet medicine人用药或兽药 Guidance documents指南文件 ICH QWP Approved guidelines批准的指南 Guidelines under discussion讨论中的指南 Filing strategies文件编撰策略 CEP ASMF/EDMF procedure ASMF/EDMF程序 ??? CEP Procedure versus the DMF Procedure CEP 程序对 DMF 程序 Guideline on Summary of requirements for active substances in the quality part of the dossier针对文件质量部分中活性物质要求的概述的指南 Classification of active substances活性物质的分类: New active substances used for the first time in a medicinal product在药品中第一次使用的新的活性成分 Existing active substances not described in the European Pharmacopoeia在欧洲药典中没有描述的现有的活性物质 Existing active substances described in the European Pharmacopoeia在欧洲药典中有描述的现有的活性物质 Application for a marketing authorisation of a Medicinal Product药品市场许可申请 requires information on the Active Substance (AS) 活性物质(AS)的要求信息: Certificate of suitability to the Monograph of the European Monograph 针对欧洲药典专论的适应性证书 Active Substance Master File (ASMF ) procedure活性物质主文件 (ASMF ) 程序 Full details of manufacture完整的制造细节 Feasible ways to submit可行的递交方式 Depending on the classification of the AS取决于活性物质的分类 For new active substances and substances not described in the Ph.Eur. : ASMF/EDMF对于在欧洲药典中没有描述的物质和新的活性物质: ASMF/EDMF For existing substances, descrribed in the Ph.Eur. : CEP or ASMF/EDMF对于在欧洲药典中描述的现有的活性物质: CEP 或 ASMF/EDMF The AS manufactu