[QA有关英语.docVIP

Technical requirement 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 EDMF compilation in CTD format :a) Module 3.2. S. Drug Substance b) Module 2.3 Quality Overall Summary CEP Procedure versus the DMF Procedure Filing strategies in EU countries Certification of suitability to the monographs of the European Pharmacopoeia Procedure ,Submission of the Dossier, Content of the Dossier/Expert Report, Assessment, Timetable, Follow-up CTD格式的EDMF的编撰:a) 模块 3.2. S. 药物物质 b) 模块 2.3 质量概述 CEP程序对DMF程序 在欧盟国家的文件编撰策略 针对欧洲药典专论的适应性证书 程序，文件递交，文件内容/专家报告，评估，时间表，后续工作 Guideline on Summary of requirements for active substances in the quality part of the dossier Classification of active substances : New active substances used for the first time in a medicinal product Existing active substances not described in the European Pharmacopoeia Existing active substances described in the European Pharmacopoeia 针对文件质量部分中活性物质要求的概述的指南 活性物质的分类: 在药品中第一次使用的新的活性成分 在欧洲药典中没有描述的现有的活性物质 在欧洲药典中有描述的现有的活性物质 requires information on the Active Substance (AS): Certificate of suitability to the Monograph of the European Monograph Active Substance Master File (ASMF ) procedure Full details of manufacture 活性物质(AS)的要求信息: 针对欧洲药典专论的适应性证书 活性物质主文件 (ASMF ) 程序 完整的制造细节 Depending on the classification of the AS For new active substances and substances not described in the Ph.Eur. : ASMF/EDMF For existing substances, descrribed in the Ph.Eur. : CEP or ASMF/EDMF The AS manufacturer provides either: No 1) CEP or No 2 the ASMF/EDMF (Applicants part be included in the MA) 取决于活性物质的分类 对于在欧洲药典中没有描述的物质和新的活性物质: ASMF/EDMF 对于在欧洲药典中描述的现有的活性物质: CEP 或 ASMF/EDMF AS 制造商提供下列两者中的一个: CEP 或 第2， ASMF/EDMF (MA包括此申请部分) Submission of the CEP Generally avoiding any subsequent reassessment AS manufacturer submits : copy of the most curent CEP Written asurance that no significant changes in the manufacturing method have taken place Applicant submits : Results of batc