cep电子版纸版递交指南中英文cepguidanceforcepapplications.docx

1、cep电子版纸版递交指南中英文cepguidanceforcepapplications201306 PA/PH/CEP(09)108 2R CEP电子提交和纸质提交指南（中英文）?官网原文下载：新版本生效日期：2013年8月1日Certification of Substances DivisionFK/CBPUBLIC DOCUMENT?公开文件(LEVEL 1)?第一层次English only/Anglais seulement?仅英文版PA/PH/CEP(09)108, 2RStrasbourg, June 2013Certification of suitability to Mo

2、nographs of the European PharmacopoeiaGuidance for electronic and paper submissionsFor Certificates of Suitability (CEP) applicationsCEP电子和纸质申报指南Date of implementation: 1 August 2013Address: 7, sllee Kastner, CS 30026F-67081 Strasbourg (France)Telephone: 33(0)3 88 41 30 30 Fax: 33 (0) 3 88 41 27 71

3、e-mail:?Internet:?Table of content?目录1?Introduction?介绍2?Scope and general requirements?范围和一般要求3?Electronic submission formats?电子申报格式3.1?eCTD submission format eCTD申报格式3.2?NeeS submission format NeeS申报格式3.3?PDF format PDF格式4?Submission of paper dossiers?纸质文件提交5?Content and structure of an application

4、?申报的内容和结构6?Lifecycle management of applications?申报的生命周期管理6.1?Granularity and updated sections?章节分类和更新部分6.2?When to submit a baseline Module 3?什么时候提交基准模块37?Validation by the EDQM EDQM验证8?Routes (or pathways) of submission?递交方式（途径）9?Security?安全性1?Introduction?介绍This document is guidance for electronic

5、 and paper submissions for Certificates of Suitability (CEPs) applications. Information and requirements described in this document are intended to facilitate the handling and assessment of submissions for certificates of suitability (CEPs) and to maintain their lifecycle even if the submission is n

6、ot an eCTD.本文件意在指导CEP的电子和纸质申报。本文件中描述的所有信息和要求意在使用CEP申报资料处理和评审更为便捷，更利于维护其生命周期，即使该申报并不是以eCTD格式提交。2?Scope and general requirements?范围和一般要求This guidance should be applied for all submissions sent to EDQM in the context of applications for CEPs, and whatever the support selected (electronic or paper).本指南适

7、用于向EDQM递交的所有CEP申报，无论选用何种格式（电子或纸质）。Currently the EDQM accepts paper dossier, as well as 3 electronic submission formats: pdf, NeeS, and eCTD. Paper submissions are still accepted but it is intended to move to 100% electronic submission in the future, therefore it is strongly recommended to initiate e

8、lectronic submissions.目前EDQM接受纸质申请和3种电子申报格式：pdf, NeeS?和eCTD。纸质申请虽然仍被接受，但将来会趋向于100%采用电子提交，因此强烈推荐初始申报即采用电子提交。Changing the format for a CEP application is possible at the start of a procedure (eg. When applying for a revision or renewal). This means moving from paper to electronic submission, moving fr

9、om a pdf to a NeesS or eCTD, or from a NeeS to eCTD.在开始程序之初对CEP申报格式进行变更是可以的（例如，在申请修订或更新时）。这时，意味着从纸质提交转为电子提交，从PDF提交转为NeesS或eCTD提交，从NeeS转为eCTD提交。Once a company has made an e-submission, changing back to paper is no longer possible.?In addition, a mixture of paper and electronic files is not allowed (o

10、nly the format chosen in the application form will be taken into consideration)一旦公司采用了电子提交，就不能再改回纸质提交。另外，纸质和电子混合提交是不允许的（仅考虑申请表格中选择的格式）。3?Electronic submission formats?电子申报格式Three possible submission formats are accepted for electronic submissions: eCTD, NeeS, or a single bookmarked PDF file for Modu

11、le 3. Submissions in eCTD format are recommended by the EDQM.有三种可以接受的电子申报格式：eCTD, NeeS和带书签的模块3单个PDF文件。EDQM建议以eCTD格式提交申报。This is applicable to all types of applications and communication. The identification of the submission format type in the CEP application form is important.这适用于所有类型的申报和信息交流。在CEP申请

12、表格中标明申报格式类型是很重要的。Electronic files should be in accordance with specific Guidance for Industry on providing Regulatory Information in Electronic Format (see the links in the sections below for each submission format).电子文件应符合相应的行业法规信息电子格式指南（见以下各部分提交格式的链接）All files should be in PDF and the folder and t

13、he file-naming convention of ICH M2 eCTD Specification and EU Module 1 Specification should be applied.?Other types of files are not accepted (Word, JPEDG, Excel, ), with the exception of the files required for publishing an eCTD submission.所有文件均应为PDF格式，文件夹和文件命名应采用ICH M2 eCTD指南，和欧盟模块1标准。其它类型文件将不被接受（

14、Word, JPEDG, Excel, ），eCTD申报公布所需文件除外。The use of attached files in a pdf file is not allowed nor are pdf files with active javascripts (form fields, ) or containing watermarks.在PDF文件中采用附件是不允许的，PDF文件中也不能有JAVA程序（表格域等），不能有水印。CEP applications for the TSE risk?TSE风险CEP申请The eCTD or NeeS submission format

15、is not appropriate for CEP applications for the TSE risk, consequently, applicants are invited to submit a single pdf for Module 3, and adapt the directory structure/file naming as proposed in annex 1.TSE风险的CEP申请不适用eCTD和NeeS申报格式，因此，要求申请人提交模块3单个PDF文件，采用附件1中目录结构和文件命名。CEP applications and products for

16、veterinary use only?仅兽用CEP申请和产品A single pdf (see annex 5) or NeeS submission format (see the guidance available by the following link?) may be used for such products.单个PDF文件（见附件5）或NeeS申报格式（见下列链接指南）可以用于该类产品。3.1?eCTD submission format?eCTD申报格式The eCTD structure should be in accordance with the current

17、 versions of the related documents (specifications, guidance, etc) available on the following websites:eCTD结构应符合现行相关文件要求（标准、指南等），这些文件在以下网址可获得?It should be clarified that the eCTD CEP dossier remains, from a technical perspective,?a standalone dossier and is distinct from any marketing authorization

18、eCTD dossier and lifecycle.需要澄清的是，从技术角度来说，eCTD格式CEP文件仍是一个单独的申报资料，区分于任何上市申请eCTD文件和生命周期。Building the envelope:?创建信封According to the current EU Module 1 specification, for a CEP application, the envelope should be filled in as follows:根据现行欧盟模块1标准，对于CEP申请，信封应填写如下Element因素Attribute属性Description/Instructi

19、ons描述/要求Eu-envelope欧盟-信封Envelope信封Country国家emaSubmission申报Type类型Active Substance Master File (asmf)活性物质主文件（asmf）Mode模式Blank空白Number编号Blank空白Tracking number追踪号Blank except if CEP application number known空白除非已知CEP申请号Applicant申报人Holder/Intended Holder name for the CEPCEP持有人/意向持有人名称Agency官方Code代码EU-EMAP

20、rocedure程序Type类型Use “centralized”采用“集成”Invented-name创建名Substance name物质名称InnRefer to the EU Module 1 specification.索引至欧盟模块1标准Sequence序列号Blank空白Submission-description提交描述Certificate of suitability/EDQMCEP/EDQMWhen submitting the first eCTD submission, an initial sequence 0000 should be provided. For

21、the content of the submission refer to the section 5.在首次eCTD提交时，初始序列号应为0000。申报资料内容参见第5部分。When switching from another submission format to eCTD, any information already assessed and approved previously should be included in a “baseline” sequence 0000 (refer to the section 6). If files or sections of

22、the eCTD contain a lot of information, additional bookmarks or “leverls of granularity” are recommended for facilitating the review (refer to annex 2). The use of bookmarks is allowed if needed, especially when responding to an EDQM deficiency letter (responses to questions and supportive data).如果是从

23、其它申报方式转换为eCTD提交，所有已经审核和批准过的内容应包括在一个“基准”序列号为0000部分（参见第6部分）。如果eCTD文件或部分包括太多信息，推荐使用更多的书签或“分层标题”以便审核（参见附件2）。书签可以在需要时使用，特别是在回复EDQM缺陷信时（回复问题的内容和支持性数据）。Before submitting an eCTD to EDQM, it should be technically validated using an appropriate checker/validation tool. If pass/fail errors are detected during

24、 EDQM validation at receipt, the submission will be blocked or rejected. The operation attributes chosen should be appropriate to allow the lifecycle of the submission (refer to section 6).在向EDQM提交eCTD之前，应采用适当的检查/验证工具进行技术验证。如果在EDQM接收验证时，发现通过/失败错误，申报会被阻止或拒收。选择的操作属性应适当，以便在生命周期内进行维护（参见第6部分）。3.2? NeeS s

25、ubmission format NeeS申报格式The NeeS structure and specification as well as the validation criteria should be in accordance with the guidance and documents available on the following website:NeeS结构和要求以及验证标准应符合相关指南，该指南和文件在以下网站可获得? The CTD file/directory structure and naming shall be implemented with the

26、 addition of a Table of Content(s) as appropriate.如适用，应有一个根据CTD文件/目录结构和命名编写的目录。If files or sections of the NeeS contain a lot of information, additional levels of granularity are recommended for facilitating the review (refer to annex 2).如果NeeS文件或部分包括特别多的信息，建议采用更多的分层标题以便审阅（参见附件2）。For the content of

27、the submission refer to section 5.申报资料内容参见第5部分。3.3? PDF format PDF格式It is possible to provide an application containing:? For Module 1, a maximum of 4 PDF files or a single PDF file book marked according to the content of Module 1 (see section 5)? 对于模块1，最多4个PDF文件，或单一PDF文件，其中根据模块1的内容做了书签（参见第5部分）? For

28、 Module 2, one single PDF file? 对于模块2，单个PDF文件? For Module 3 a single PDF file containing all the appropriate sections and compliant with the CTD requirements (naming convention etc.). The structure given in annex 5 has to be applied and bookmarks should be included using an acceptable granularity (S

29、ee annex 2)? 对于模块3，采用PDF单个文件，包括所有适当的部分，符合CTD要求（正规命名等）。必须采用在附件5中给出的结构，应包括根据层次标记的书签（见附件2）。A single file containing all the Modules 1, 2 and 3 is not allowed. For the content of the submission refer to the section 5.不允许在单一PDF文件中包括模块1、2和3。申报资料内容参见第5部分。 The use of bookmarks is strongly recommended for Mo

30、dule 1, especially when responding to an EDQM deficiency letter (responses to questions and supportive data).强烈推荐在模块1中使用书签，特别是对于EDQM缺陷信的回复（回复问题及提及支持性数据）4? Submission of paper dossiers 纸质文件提交Paper submissions are scanned at receipt at EDQM, therefore the clock-start for the dossier may be delayed acc

31、ordingly (the delay increases with the volume of the submission). After validation, the paper documents are destroyed and the electronic copies are used by EDQM.EDQM在收到纸质申请后，会进行扫描，因此文件开始审核的时间可能顺延（延迟时间会因为申报资料的内容增加而增加）。在经过验证后，纸质文件会被销毁，EDQM会使用扫描的电子文件。The structure to be followed is the same as for the pdf format (refer to annex 5), with the Modules 1, 2 and 3 being separated. The CTD structure shall be implemented