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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 Pr
2、ocedure 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 在欧盟国家的
3、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 CEP
4、ASMF/EDMF procedure ?文件编撰策略 CEP ASMF/EDMF程序 ?CEP Procedure versus the DMF ProcedureGuideline on Summary of requirements for active substances in the quality part of the dossierClassification of active substances :1. New active substances used for the first time in a medicinal product2. Existing acti
5、ve substances not described in the European Pharmacopoeia3. Existing active substances described in the European PharmacopoeiaCEP 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:1. 在药品中第一次使用的新的活性成分2. 在欧洲药典中没有描述的现有的活性物质3. 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 requir
6、es information on the Active Substance (AS):1. Certificate of suitability to the Monograph of the European Monograph2. Active Substance Master File (ASMF ) procedure 3. Full details of manufacture 药品市场许可申请活性物质(AS)的要求信息:1. 针对欧洲药典专论的适应性证书2. 活性物质主文件 (ASMF ) 程序 3. 完整的制造细节 Feasible ways to submit Dependi
7、ng on the classification of the AS1. For new active substances and substances not described in the Ph.Eur. : ASMF/EDMF2. For existing substances, descrribed in the Ph.Eur. : CEP or ASMF/EDMFThe AS manufacturer provides either:No 1) CEP or No 2 the ASMF/EDMF (Applicants part be included in the MA)可行的
8、递交方式取决于活性物质的分类1. 对于在欧洲药典中没有描述的物质和新的活性物质: ASMF/EDMF2. 对于在欧洲药典中描述的现有的活性物质: CEP 或 ASMF/EDMFAS 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 CEPGenerally avoiding any subsequent reassessmentAS manufacturer submits : copy of the most curent CEP Written asurance that no significant cha
9、nges in the manufacturing method have taken placeApplicant submits : Results of batch analysis demonstrating compliance with the Ph.Eur. MonographCEP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 procedureGuideline on Active Substance Master File proce
10、dure :v CPMP/QWP/227/02v Terms European Drug Master File (EDMF) and Active Substance Master File (ASMF) are interchangable v Overview EDMF contentv Template letter of access and covering letterASMF/EDMF程序活性物质主文件程序的指南:v CPMP/QWP/227/02v 欧洲药物主文件(EDMF)和活性物质主文件(ASMF)的条款可以通用v EDMF内容概览v 准阅信和封面信的模板ASMF/EDM
11、F procedure 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 contro
12、l during manufacture 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 SubmissionEDMF can only be submitted in support of an MAA EDMF Holder should submit to to thethe MA holder MA holder: Copy of the latest version o
13、f the AP Copy of the QOS Letter of access AP contains information non- condidental EDMF Holder should submit to to the authoritiesthe 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 MAMA的持有者的持有者: 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到
14、官方部门官方部门 有封面信的完整EDMF 准阅信ARED E. TIEFENBACHER (GmbH e.g Benzene in ToluolStarting material : justification, characterisation, specification , including potential impuritiesDiscussion of possible carrying through of impurities Analytical test methods descriptionIn case the synthesis of API consits of
15、only one or a few steps , manufacture of the staring material should be given If more than one supplier of the starting material is used, batch analysis results from the API manufactured from the different suppliers to be given3.2.S.2.3 物料控制原料和溶剂的规格，适当的如果在溶剂中可能有一类溶剂应注明其规格和检测方法；如：甲苯中的苯起始物料: 评定，性状，规格，
16、包括潜在杂质讨论运行中可能的杂质分析检测方法的描述如果原料药的合成仅有一步或几步构成，起始物料的制造应详细描述如果所使用的起始物料的供应商不只一个，从不同的供应商生产而来的原 料药的批分析结果应被提供。3.2.S 2.4 Control of Critical steps and intermediates :Critical steps definition: where process conditions , test requirements or other relevant parameters must be controlled within the predetermined limits to ensure that AS meets specification De
