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1、,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,EDMF compilation in CTD format : a) Module 3.2. S. Drug Substance b) Module 2.3 Quality Overall Summary CEP Procedure versus the DMF P
2、rocedure 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,技术要求,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
3、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,How to get the guideline from the Internet ?,www.emea.eu.int Human medicine or vet medicine Guidance documents ICH QWP Approved guidelines Guidelines under discussion,如何从互联网得到指南?,www.emea.eu.int 人用药或兽药 指南文件 ICH QWP 批准的指南 讨论中的指南,Filing strategies,C
4、EP ASMF/EDMF procedure ?,文件编撰策略,CEP ASMF/EDMF程序 ?,CEP Procedure versus the DMF Procedure,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 a
5、ctive substances not described in the European Pharmacopoeia Existing active substances described in the European Pharmacopoeia,CEP 程序对 DMF 程序,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,Application for a marketing authorisation of a Medicinal Product,require
6、s 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,药品市场许可申请,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,Feasible ways to submit,Depending on the clas
7、sification 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),可行的递交方式,取决于活性物质的分类
8、 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: 第1， 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 m
9、anufacturing method have taken place Applicant submits : Results of batch analysis demonstrating compliance with the Ph.Eur. Monograph,CEP的递交,通常应避免下列任何的重新评估 作为制造商递交: 最新的CEP的复印件 书面保证：在采用的制造方法中没有发生重大变更 申请人递交: 批分析结果要证明符合欧洲药典专论的要求,ASMF/EDMF procedure,Guideline on Active Substance Master File procedure :
10、 CPMP/QWP/227/02 Terms European Drug Master File (EDMF) and Active Substance Master File (ASMF) are interchangable Overview EDMF content Template letter of access and covering letter,ASMF/EDMF程序,活性物质主文件程序的指南: CPMP/QWP/227/02 欧洲药物主文件(EDMF)和活性物质主文件(ASMF)的条款可以通用 EDMF内容概览 准阅信和封面信的模板,ASMF/EDMF procedure,
11、Overall content of the ASMF/EDMF as indicated in NTA/CTD format Module 3 AP contains information non-condidental RP contains remaining information such as : Detailed information on the manufacturing steps (reaction conditions, temperature etc.) Evaluation of critical steps Quality control during man
12、ufacture Validation,ASMF/EDMF程序,按照NTA/CTD格式模块3的指示做ASMF/EDMF的全部内容 AP包含非保密的信息 RP包含剩余的如下信息: 制造步骤的详细信息 (反应条件，温度，等等) 关键步骤的评估 制造中的质量控制 验证,ASMF/EDMF Submission,EDMF can only be submitted in support of an MAA EDMF Holder should submit to the MA holder: Copy of the latest version of the AP Copy of the QOS Le
13、tter of access AP contains information non-condidental EDMF Holder should submit to the authorities Complete EDMF with covering letter Letter of access,ASMF/EDMF递交,EDMF只能在MAA的支持下递交 EDMF的持有者递交到 MA的持有者: AP的最近版本的复印件 QOS的复印件 EDMF持有者应当把AP包含的非保密内容的准阅信递交到官方部门 有封面信的完整EDMF 准阅信,ARED E. TIEFENBACHER (GmbH & Co
14、) Van-der-Smissen-Str. 1 22767 Hamburg Germany Tel.: +49-40-441809-0 Fax.: +49-40-441809-26 Mail.: ,ARED E. TIEFENBACHER (GmbH & Co) Van-der-Smissen-Str. 1 22767 Hamburg Germany Tel.: +49-40-441809-0 Fax.: +49-40-441809-26 Mail.: ,Preparation and Filing of EDMF/ASMF for COS/CEP applicationies,申请CO
15、S/CEP的 EDMF/ASMF文件制作,Technical Requirements,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 Pr
16、ocedure ,Submission of the Dossier, Content of the Dossier/Expert Report, Assessment, Timetable, Follow-up,技术要求,CTD格式的EDMF的编写： a) 模块 3.2. S. 药物物质 b) 模块 2.3 质量综述 CEP程序对DMF程序 欧盟国家的文件编排策略 欧洲药典专论的适应性证明 程序，文件的递交，文件目录/专家报告，评估，时间表，跟踪执行,Certification procedure,Application at the EDQM (European Directorate for the Quality of Medicines) How to apply ? Application form Procedere Timetable,COS证明程序,在EDQM申请（药品质量欧洲理事会
