CTD中文版.doc

1、European Union 欧盟Administrative Information and Prescribing Information行政信息和法规信息 Edition May 20082008年5月版Module 1 Table of Content 模块1 内容简介1.0 Cover Letter 封面信1.1 Comprehensive Table of Contents 内容简介1.2 Application Form 申请格式1.3 Product Information 产品信息1.3.1 SPC, Labelling and Package Leaflet SPC, SP

2、C 标签和包装传单1.3.2 Mock-up 实验数据 1.3.3 Specimen 样品1.3.4 Consultation with Target Patient Groups 咨询目标病人1.3.5 Product Information already approved in the Member States在欧盟成员国已批准的产品信息1.3.6 Braille 盲文1.4 Information about the Experts 专家信息1.4.1 Quality 质量1.4.2 Non-Clinical 非临床1.4.3 Clinical 临床1.5 Specific Requ

3、irements for Different Types of Applications 对于不同申请的特殊要求1.5.1 Information for Bibliographical Applications 关于生物信息的申请1.5.2 Information for Generic, Hybrid or Bio-similar Applications 非专利药，混合物和生计学药品申请1.5.3 (Extended) Data/Market Exclusivity （扩展）数据市场排他性1.5.4 Exceptional Circumstances 异常情况1.5.5 Conditio

4、nal Marketing Authorisation 市场经营许可1.6 Environmental Risk Assessment 环境风险评估1.6.1 Non-GMO 非转基因生物 1.6.2 GMO 转基因生物NTA, Vol. 2B-CTD, Module 1 edition May 2008 3 1.7 Information relating to Orphan Market Exclusivity 关于特药市场排他性1.7.1 Similarity 相似性1.7.2 Market Exclusivity 市场的排他性1.8 Information relating to Ph

5、armacovigilance 药物警戒性相关信息1.8.1 Pharmacovigilance System 药物警戒性系统1.8.2 Risk-management System 风险管理系统1.9 Information relating to Clinical Trials 临床相关细节问题1.10 Information relating to Paediatrics 儿科的相关信息Responses to Questions 相关问题的回答Additional Data 相关数据1.0 Cover Letter 封面信The cover letter to the applicat

6、ion should be included here.申请用的封面信必须包含下列内容Where necessary, a “Notes to Reviewers” document could be provided as an Appendix to the cover letter, providing further information in order to facilitate navigation (e.g. on hyper linking, volumes presentation etc .).在必要的时候请在封面信的后面标明“检查者须知”，以便将来提供相关信息For

7、paper submissions, only the relevant cover letter for the Member State concerned /EMEA should be provided.必须提供以前向相关成员国递交的书面申请，或者向欧洲人用和兽用药品委员提供递交过的申请。1.1 Comprehensive Table of Contents 内容简介A comprehensive table of contents should be provided for each type of application, reflecting all module sectio

8、ns submitted as part of the application concerned. For New Applications, all sections should be addressed (see also introduction).每种类型的申请必须提供详细的目录，申请表中必须包含模块中的全部信息。对于新的申请方式，需要写出所有的部分（具体参见“简介”）The Table of Contents should reflect the granularity of the dossier submitted, taking into account the Annex

9、 to the M4 ICH guideline on organisation of the CTD,published on: http:/www.ich.org 内容目录能准确的反映出提交文件的时间的间隔，将M4 ICH提交到附录中Module 1:1.0 Cover Letter 说明信 1.1 Comprehensive Table of Contents 目录1.2 Application Form 申请格式1.3 Product Information 产品信息1.3.1 SPC, Labelling and Package Leaflet 包装配置，标签和标签传单1.3.2 M

10、ock-up 实验（模拟数据）1.3.3 Specimen 样品1.3.4 Consultation with Target Patient Groups 咨询目标病人1.3.5 Product Information already approved in the Member States在欧盟成员国已批准的产品信息1.3.6 Braille 盲文1.4 Information about the Experts 专家信息1.4.1 Quality 质量1.4.2 Non-Clinical 非临床1.4.3 Clinical 临床1.5 Specific Requirements for

11、Different Types of Applications对于不同申请的特殊要求1.5.1 Information for Bibliographical Applications 关于生物信息的申请1.5.2 Information for Generic, Hybrid or Bio-similar Applications 非专利药，混合物和生计学药品申请1.5.3 (Extended) Data / Market Exclusivity（扩展）数据市场独家经营权1.5.4 Exceptional Circumstances 异常情况1.5.5 Conditional Marketi

12、ng Authorisation 市场经营许可1.6 Environmental Risk Assessment 环境风险评估1.6.1 Non-GMO 非转基因生物1.6.2 GMO 转基因生物 1.7 Information relating to Orphan Market Exclusivity关于特药市场1.7.1 Similarity 相似性1.7.2 Market Exclusivity 市场的排他性1.8 Information relating to Pharmacovigilance 药物警戒性相关信息1.8.1 Pharmacovigilance System 药物警戒性

13、系统1.8.2 Risk-management System 风险管理系统1.9 Information relating to Clinical Trials 临床相关细节问题1.10 Information relating to Paediatrics 儿科的相关信息Responses to Questions 相关问题的回答Additional Data 相关数据Module 2: Common Technical Document Summaries CTD 文件摘要2.1 CTD Table of Contents (Module 2 5) CTD文件目录（2-5模块）2.2 In

14、troduction 简介2.3 Quality Overall Summary Introduction 质量摘要-附录2.3.S Quality Overall Summary Drug Substance 质量摘要-原料药 2.3.P Quality Overall Summary Drug Product 质量摘要-药品 2.3.A Quality Overall Summary Appendices 质量摘要-附录2.3.R Quality Overall Summary Regional Information 质量摘要-地区信息2.4 Nonclinical Overview 非

15、临床概述2.5 Clinical Overview 临床概述2.6 Nonclinical Written and Tabulated Summaries 书面临床摘要和列表的摘要2.6.1 Introduction 简介2.6.2 Pharmacology Written Summary 药理学书面摘要2.6.3 Pharmacology Tabulated Summary 药理学列表摘要2.6.4 Pharmacokinetics Written Summary 药物代谢学摘要2.6.5 Pharmacokinetics Tabulated Summary 药物代谢学列表摘要2.6.6 T

16、oxicology Written Summary 毒理学书面摘要2.6.7 Toxicology Tabulated Summary 毒理学列表摘要2.7 Clinical Summaries 临床摘要2.7.1 Summary of Biopharmaceutic and Associated Analytical Methods 生物药剂学摘要和分析摘要2.7.2 Summary of Clinical Pharmacology Studies 临床药理学摘要2.7.3 Summary of Clinical Efficacy 临床功效摘要2.7.4 Summary of Safety

17、安全性摘要2.7.5 References 参考文献2.7.6 Synopses of Individual Studies 个例研究和症状Module 3: Quality 质量3.1 Module 3 Table of Contents 第三模块的目录3.2 Body of Data 数据主体3.3 Literature References 参考文献Module 4: Nonclinical Study Reports 非临床研究报告4.1 Module 4 Table of Contents 第四模块的目录4.2 Study Reports 研究报告4.3 Literature Ref

18、erences 参考文献Module 5: Clinical Study Reports 临床报告5.1 Module 5 Table of Contents 第五模块目录5.2 Tabular Listing of All Clinical Studies 所有临床研究清单5.3 Clinical Study Reports 临床研究报告5.4 Literature References 参考文献 1.2 Application Form 申请格式Module 1.2 is to be used for an application for a marketing authorisation

19、 of a medicinal product for human use submitted to 11.2模块是用来申请人用药品的市场授权(a) the European Medicines Agency under the centralised procedure or 集中程序控制下的欧洲药品机构(b) a Member State (as well as Iceland, Liechtenstein and Norway) under either anational, mutual recognition or decentralised procedure. 在国家或者联邦，分

20、散程序控制下的成员国（如：冰岛、列支敦士登（欧洲国家），挪威）The relevant application form has to be included, depending on the type of application.根据申请类型的不同，也应当包括相关的申请表格，The different application forms are available on the Website of the European Commission / 不同的申请表格可以通过欧洲委员会的网站查到DG Enterprise: 􀂃 New Applications and E

21、xtension Applications 新的申请表格http:/ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm#2b􀂃 Variation applications 变更申请http:/ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm#2c􀂃 Renewal applications 更新申请http:/ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.

22、htm#2c1.3 Product Information 产品信息In accordance with Article 8.3 (j), Article 11 and Title V of Directive 2001/83/ECapplicants/marketing authorisation holders must include proposals for (revised) Summary of Product Characteristics (SPC), labelling and package leaflet in their application.根据8.3条款，市场授

23、权持有人必须在申请时提供产品特性概述，标签和包装1.3.1 SPC, Labelling and Package Leaflet产品特性概述，标签和包装The national competent authorities and the EMEA have published templates in all EU languages (incl. Norwegian and Icelandic) for the presentation of product information(Summary of Product Characteristics (SPC), labelling and

24、 package leaflet): For mutual recognition or decentralised procedures: the templates for productinformation are published on the Heads of Agency website (annotated template) andon the EMEA website (clean templates)国家的权利机构和欧洲人用和兽用药品委员会已经联合出版模板，介绍产品信息（产品特性概述、标签和包装）等用欧洲官方语言（其中包括挪威语和冰岛语）。分散程序控制下，根据权威机构网

25、站上（有注解的样本）和人用和兽用药品委员会网站上（清洁样本）发布的产品信息的样本。http:/heads.medagencies.org/mrfg/docs/pi/QRD_annotated_template_CMDh.pdfhttp:/www.emea.europa.eu/htms/human/qrd/qrdtemplate.htm For applications in the centralised procedure: the templates for product information are published on the EMEA website (annotated and clean templates)集中控制程序的申请：人用和兽用药品委员会网站上（注解样本和清洁样本）发布的产品信息的样本http:/www.emea.europa.eu/htms/human/qrd/qrdtemplate.htmProduct information must only be presented in the mandatory format and lay-out (see“QRD convention” on the EMEA Website) usin