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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 a

26、nd 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) using the electronic product informationtemplates provided on

27、 the EMEA Website.EMEA网站上提供的电子产品信息样本，以代理的形式和规划来提供产品信息（参见：EMEA网站上见“QRD标准”）A complete set of SPC/Annex II/Labelling/Package Leaflet texts, as appropriateshould be presented per language (in alphabetical order). Relevant guidancedocuments which address the submission and presentation of product informa

28、tion inpaper and electronic format should be consulted when preparing this section ofModule 1 (e.g. QRD Templates, EMEA Post-Authorisation Guidance document)一套完整的产品特性概述 /附件二/标签/包装的文稿，最好是每种语言都有(按字母顺序排列)。关于第一模块的相关的产品信息，应该以书面或者电子版的形式提交（例子：QRD样本，EMEA的授权指导文件）For national procedures other national templat

29、es may apply 申请一个国家的程序，其它国家的样本也是可以参照的These templates should be used in conjunction with the relevant guidelines. In particular with the “Guideline on Summary of Product Characteristics”, the “Guideline on packaging information” and the “Guideline on the Readability of the Label and Package Leaflet o

30、f Medicinal Products for Human Use, as published by the European Commission in the Notice To Applicants, Vol. 2C:(http:/ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm#2c).使用这些模板应该结合相关指导方针。特别是 “产品特性总结”方面的相关方针，“包装信息方面的指导方针”，“人类使用药品包装信息指引的可读性”,公布欧洲议会的通知申请人于卷,第3期(http:/ec.europa.eu/enterpri

31、se/pharmaceuticals/eudralex/homev2.htm # 2C)。For the paper submission of product information: 产品信息书面申请different language versions should be separated by a tab SPC, (Annex II), labelling and package leaflet should be separated by a tab, for submission to CHMP members/Member States, only the relevant

32、language version(s) are to be provided in addition to the English product information, as required.不同的语言版本可以用标签分开,产品特性总结（附录II），标签和包装说明应该用标签分开向欧盟药品管理委员会及其成员国提交申请时，除了用英语来翻译产品信息，请根据要求递交其它语言的申请文件。1.3.2 Mock-up 模拟实验In accordance with Directive 2001/83/EC, Article 8, a mock-up of the outer and immediate p

33、ackaging of the medicinal product must be included with the application.A “mock-up” is a copy of the flat artwork design in full colour, providing a replica of both the outer and immediate packaging, providing a two-dimensional presentation of the packaging/labelling of the medicinal product. It is

34、generally referred to as a “paper copy” or “computer generated version”.根据2001 / 83 / EC指令、第八条，药品和中间体药品包装的模拟品，应当包括在申请中。“模拟包装品的设计应该是彩色的，是外包装和中间品包装的复制品，提供的是产品包装和标签的二维表现形式。一般被认为是“复制品”或者是“电脑生成的版本”Requirements for mock-up and/or specimen submission are published by theEuropeanCommission in the Notice to

35、Applicants, Vol. 2A, Chapter 7对于模型的要求或者是样品提交的要求必须是由欧洲委员会申请人须知,2卷，第七章。(http:/ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm#2a)When mock-ups are submitted, a list detailing the mock-ups provided with the application should be included in addition to the actual mock-ups.当“模拟品”提交后，应当在申请表中提

36、出模拟品的列表以及相关信息。Module 1.3.3 Specimen 样品A “specimen” is a sample of the actual printed outer and immediate packaging materials and package leaflet.样品是指实际生产中打印后的外包装和中间体产品的包装，和产品说明书Member States/EMEA may require specimens of the sales presentation of the medicinal product to be submitted, in order to ch

37、eck compliance with the relevant articles in Title V of Directive 2001/83/EC (e.g. Article 56).成员国/ EMEA也许会要求出售药品的样品，以便考察是否符合有关规定2001/83/EC(例如。第五十六条)Requirements for mock-up and/or specimen submission are published by the European Commission in the Notice to Applicants, Vol. 2A, Chapter 7(http:/ec.e

38、uropa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm#2a)对于模型的要求或者是样品提交的要求必须是由欧洲委员会申请人须知,2卷，第七章。When specimens are submitted, a list detailing the specimens provided should be included. For the electronic submission of Module 1, only the list detailing the specimens should be included here, separa

39、te from the actual specimens provided.当提交样品之后，应该上交一份样品清单。以电子版的形式上交第一模块，给出提供样品的细节，并且与真实的样品分开提供。1.3.4 Consultation with Target Patient Groups 咨询目标病人Articles 59(3) and 61(1) of Directive 2001/83/EC require that the package leaflet reflects the results of consultations with target patient groups to ensu

40、re that it is legible, clear and easy to use, and that results of assessments carried out in cooperation with target patient groups be provided to the competent authority/EMEA.条款59岁(3)和61(1)2001 / 83 / EC指令的要求包装说明书反映出与目标患者团体咨询结果,以确保它们是清晰的,明确的和方便使用的,于目标患者团体的评估结果应当提供给权利机构EMEAThese articles do not defi

41、ne the precise method to be used. As a consequence, these provisions permit user testing as well as other appropriate forms of consultation.这些条款并没有明确规定使用方法。因此,本规定允许“用户测试”以及其他适当形式的咨询。This is addressed in the draft EU guidance document published on the website of theEuropean Commission:http:/ec.europa

42、.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2005/08_05/usertesting_20050817.pdf ，which will be included in the Commission “Guideline on the readability of the label and package leaflet of medicinal products for human use”, (see Website of the European Commission: http:/ ec.europa.eu/enterprise/

43、pharmaceuticals /eudralex/homev2.htm#2c)欧盟的指导文件是由欧洲的官方委员会在网上公布。http:/ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2005/08_05/usertesting_20050817.pdf。这其中包括“人用药品说明书的可读性”。（详情参加欧盟委员会）http:/ ec.europa.eu/enterprise/pharmaceuticals /eudralex/homev2.htm#2c)Information from the applicant regar

44、ding the user consultation performed together with the presentation of results, or a justification not performing such consultation, is to be included in this section for all new applications and for relevant post-authorisation applications introducing significant changes to the package leaflet.申请者所

45、提供的有关“使用咨询”结果应该与治疗结果一起上交，或者提供咨询结果的相关证明文件。对于所有的申请必须对权利机关提供产品外包装的变更Module 1.3.5 Product Information already approved in theMember States在欧盟成员国已批准的产品信息Module 1.3.6 Braille 盲文In accordance with Article 56a of Directive 2001/83/EC the name of the medicinal product must be expressed in Braille format on t

46、he packaging.依照条款56a 2001 / 83 / 欧盟指令，药品的名字在外包装上必须以盲文的形式印刷。This is addressed in the European Commission guidance document published on the website of the European Commission欧盟的指导文件是由欧洲的官方委员会在网上公布。http:/ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2005/04_05/braille_text20050411.pdf, whi

47、ch will be included in the Commission“Guideline on the readability of the label and package leaflet of medicinal products for human use”, (see Website of the European Commission:http:/ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm#2c)这其中包括“人用药品说明书的可读性”。（详情参加欧盟委员会）Applicants should addre

48、ss here the proposed implementation of the Braille requirement on the packaging of the medicinal product concerned, based on the principles set-out in the abovementioned European Commission guidance document. 申请者可根据药品包装盲文的相关要求记载，主要根据欧盟委员会的指导文件申报In addition, the Braille text (in normal font) which wi

49、ll be printed on the outer carton in Braille needs to be included in section 16 of the outer carton product information templates (if applicable) and should be indicated with dots on the mock-ups (where applicable and feasible).另外，印刷在外包装纸盒上的盲文请根据外包装相关申请文件办理。附加上模拟实验品。1.4 Information about the Experts

50、 专家信息In accordance with Article 12 of Directive 2001/83/EC experts must provide detailed reports of the documents and particulars which constitute Modules 3, 4 and 5.In addition Article 12.1 and Part I 1.4 of Annex I of 2001/83/EC refer to signed expert reports for the different scientific parts of

51、the dossiers.根据2001 / 83 / EC第十二条，专家应该为第3.4.5模块提供详细的信息和具体的文件。此外第12.1条和第一部分1.4附件是指根据2001 / 83 / EC的涉及到文件中的科研部分有专家签名。The requirement for these signed Expert Reports may be met by providing:关于专家提供的报告应该包括以下条款 The Quality Overall Summary, Non-clinical Overview / Summary and ClinicalOverview / Summary in

52、Module 2,质量总结，非临床总结，第2模块的临床总结 A declaration signed by the experts in Module 1.4. 由专家署名的1.4模块 A brief information on the educational background, training and occupationalexperience in Module 1.4.关于1.4模块的教育背景，职业培训的简要信息For post-authorisation applications, the relevant expert declaration(s) must be prov

53、ided.In cases where marketing authorisation holders wish to distinguish such declaration from any previous declarations, the relevant procedure number of the reference member state/EMEA may be included on top.对于相关授权的申请，相关专家应该提供声明等信息。如果授权经销人希望此类声明与以前的声明区分开来，那么欧盟的成员国应该列在前面。1.4.1 Quality 质量According to

54、 his / her respective qualifications the undersigned expert declares hereby to have performed the duties set out in the Article 12 and in accordance with Annex I, Part I 1.4 of Directive 2001/83/EC.据此，有署名的专家的相关资质请在2001 / 83 / EC 附录I中提供出来QUALITY : 质量Name of the expert:专家姓名Signature: 签字Address: 地址.Dat

55、e: 日期According to the Annex I of Directive 2001/83/EC brief information (curriculum vitae) on the educational background, training and occupational experience of the expert is attached.根据附件一中2001 / 83 / EC中的简明信息(简历)在学历、培训和职业经验的专家附呈。1.4.2 Non-Clinical 非临床研究According to his / her respective qualificat

56、ions the undersigned expert declares hereby to have performed the duties set out in the Article 12 and in accordance with Annex I, Part I 1.4 of Directive 2001/83/EC。据此，有署名的专家的相关资质请在2001 / 83 / EC 附录I，1.4部分中提供出来NONCLINICAL (pharmacology, pharmacokinetic, toxicology):非临床（药学，药物代谢动力学，毒理学）Name of the ex

57、pert:专家姓名Signature:签字.Address: 地址.Date: 日期According to the Annex I of Directive 2001/83/EC brief information (curriculum vitae) on the educational background, training and occupational experience of the expert is attached.根据附件一中2001 / 83 / EC中的简明信息(简历)在学历、培训和职业经验的专家附呈。1.4.3 Clinical 临床反应According to his / her respective qualifications the undersigned expert declares hereby to have performed the duties set out in the Article 12 and in accordance with Annex I, Part I 1.4 of Directive 2001/83/EC据此，有署名的专家的相关资质请在2001 / 83 / EC 附录I，1.4部分中提供出来CLINICAL: 临床反应Name of the expert:专家姓名.