翻译：julia  来源： Julia法规翻译

1.   Introduction概述

This document provides guidance forelectronic submissions for Certificate of Suitability (CEPs) applicationssubmitted to the EDQM. Information and requirements described in this documentare intended to facilitate the handling and assessment of submissions for CEPsand to maintain their lifecycle even if the submission is not an eCTD.

本文件为提交给EDQM的CEP申请提供电子申报指南。在本文件中所描述的信息和需求意在便于CEP申报资料的处理和评审，以及其生命周期维护（即使申报资料并不是eCTD）。

2.  Scopeand general requirements范围和一般要求

Thisguidance should be applied for all electronic submissions sent to EDQM in thecontext of applications for CEPs.

本指南适用于所有CEP申报过程中发送给EDQM的电子申报资料。

EDQM does not accept any paperapplications. All submissions should be in electronic format.

EDQM不接受任何纸质申报资料。所有申报均应为电子格式。

The following electronic submissionformats are accepted: PDF, NeeS, VNeeS and eCTD, but the acceptability of theformat depends on the type of submission as described in section 3.

以下电子申报格式可以接受：PDF、NeeS、VNeeS 和 eCTD，但不同申报类型的格式是否可接受以第3部分所述为准。

Changingthe electronic format for a CEP application is possible at the start of aprocedure (e.g. when applying for a revision or renewal). This means movingfrom PDF to NeeS or eCTD, or from NeeS to eCTD. Coming back to a previoussubmission format is not allowed (e.g. sending a NeeS submission whenpreviously an eCTD submission was sent.)

在开始一个程序时可以改变CEP申报的电子格式（例如，在申请修订或更新时）。这意味着从PDF转为NeeS或eCTD，或从NeeS转为eCTD。不允许退回之前的申报格式（例如，不能在之前提交了eCTD申报之后再以NeeS格式提交）。

3.  Electronicsubmission formats电子申报资料的格式

For new CEP applications,eCTD format is required (except for applications for the TSE risk and for substancesfor veterinary use only, see below).

新的CEP申报资料需要采用eCTD格式（除了TSE风险和仅供兽用申报以外，参见以下内容）。

For revisions, renewals andnotifications, the following possible submission formats are accepted: eCTD orNeeS. Submissions in eCTD format are recommended by the EDQM.

修订、更新和通知时，可以接受以下申报格式：eCTD和NeeS。EDQM建议采用eCTD格式提交申报资料。

The identification of the submissionformat type in the CEP application form is important.

CEP申报表格中申报格式类型的识别号很重要。

Electronic files should be inaccordance with specific Guidance for Industry on Providing RegulatoryInformation in Electronic Format (see the links in the sectionsbelow for each submissionformat).

电子文件应符合具体的“以电子格式提交注册信息行业指南”（参见以下部分链接中每种申报格式）。

Allfiles should be in PDF and the folder and file-naming convention of ICH M2 eCTDSpecification and EU Module 1 Specification should be applied. Other types of files arenot accepted (Word, JPEG, Excel,...), with the exception of the files requiredfor publishing an eCTD submission.

所有文件均应为PDF格式，文件夹和文件命名应遵守ICH M2 eCTD标准和EU模块1标准。不接受其它类型的文件（Word、JPEG、Excel……），eCTD申报资料所需的发布文件除外。

The use of attached files in a pdffile is not allowed nor are pdf files with active javascripts (form fields,…)or containing watermarks.

不允许在PDF文件中使用附加文件，也不允许在PDF中使用激活的java脚本（表格域……）或放置水印。

CEP applications for theTSE risk TSE风险CEP申报

The eCTD or NeeS submission format isnot appropriate for CEP applications for the TSE risk, consequently, applicantsare invited to submit a single PDF for Module 3, and adapt the directorystructure/file naming as proposed in annex 1.

eCTD或NeeS申报格式不适合于TSE风险的CEP申报，因而，诚请申报人为模块3提交单一PDF文件，并采纳附录1所指的目录结构/文件命名。

CEP applications forsubstances for veterinary use only仅供兽用物质的CEP申报

eCTD, NeeS (forrevisions/renewals) or VNeeS format may be used for such products (see guidanceavailable by the following linkhttp://esubmission.ema.europa.eu/tiges/vetesub.htm).

此类产品可以使用eCTD、NeeS（修订/更新）或VNeeS格式（参见上述链接指南）。

3.1.       eCTD submission format电子申报资料格式

The eCTD structure should be inaccordance with the current versions of the related documents (specifications,guidance, etc.) available on the following websites:

eCTD结构应依据以下网页中提供的相关文件的现行版本制订：

-     http://esubmission.ema.europa.eu

-     http://estri.ich.org/eCTD/index.htm

It should be clarified that the eCTDCEP dossier remains, from a technical perspective, a  s t andalo n e dossier and is distinctfrom any marketing authorisation dossier and lifecycle.

要澄清的是eCTD格式的CEP文档从技术角度来说仍然是一份独立的文档，与任何上市许可文档和生命周期是区分开的。

Whensubmitting the first eCTD submission, an initial sequence 0000 should beprovided. When switching from another submission format to eCTD, it is stronglyrecommended to include any information already assessed and approved previouslyin a “baseline” sequence 0000 (refer to section 5). If files or sections of theeCTD contain a lot of information, additional bookmarks or “levels of granularity”are recommended for facilitating the review (refer to annex 2). The use of bookmarks isallowed, especially when responding to an EDQM deficiency letter (responses toquestions and supportive data).

在提交首个eCTD申报资料时，应使用初始序列号0000.如果是从其它申报格式转换为eCTD，强烈建议在“基准”序列0000（参见第5部分）中包括之前已审评和批准的所有信息。如果eCTD文件或部分包括许多信息，建议制作更多的书签或“层级”有便于审评（参见第2部分）。允许使用书签，尤其是在回复EDQM缺陷信时（回复问题和支持性数据）。

Beforesubmitting an eCTD to EDQM, it should be technically validated using anappropriate checker/validation tool. If pass/fail errors are detected duringEDQM validation at receipt, the submission will be blocked or rejected.

在提交eCTD给EDQM之前，应使用适当的检查工具/验证工具进行技术验证。如果在EDQM接收验证中发现成功/失败错误，则申报资料会被打回或拒收。

Theoperation attributes chosen should be appropriate to allow the lifecycle of thesubmission (refer to section 5).

所选操作属性应适当，以便于申报资料的生命周期管理（参见第5部分）。

Building the envelope andmodule 1:在模块1中设定信封信息：

Accordingto the current EU Module 1 specification (3.0.1 and 3.0.2 in January 2018) theenvelope for a CEP application should be filled in as follows:

依据当前EU模块1的标准（2018年8月3.0.1和3.0.2），CEP申报的信封应如下填写：

For existing sequences based on oldDTD versions, the DTD version should ideally be changed at the start of a new regulatoryactivity.

如果有些序列下的申报还是基于旧的DTD版本，在开始新的注册活动时最好更改DTD版本。

Thecountry code “edqm” should be selected for the application form and otherdocuments in module 1, according to the current EU M1 Specification, availableon the following website: http://esubmission.ema.europa.eu/eumodule1/index.htm

根据当前的EU M1标准，在申报表和模块1的其它文件中应选择国家代码“edqm”。该标准在上述网址中可以下载。

3.2.       NeeS submission formatNeeS申报格式

The NeeS structure and specificationas well as the validation criteria should be in accordance with the guidanceand documents available on the following website:http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html

NeeS结构和标准及其验证标准应符合相关指南，该指南文件在上述官网可下载。

The CTD file/directory structure andnaming shall be implemented with the addition of a Table of Content(s) asappropriate.

CTD文件/目录结构和命名在执行时应增加目录表（适当时）。

If files or sections of theNeeS contain a lot of information, additional levels of granularity are recommended forfacilitating the review (refer to annex 2).

如果NeeS文件或部分包括了大量的资料，建议增加分层以便于审评（参见附录2）。

4.  Contentand structure of an application申报资料的内容和结构

Annexes 3 and 4 describe howto structure a CEP application in eCTD or NeeSsubmission formats.

附录3和附录4描述了eCTD和NeeS申报格式中的CEP资料结构。

Annex 1 describesthe recommended file/directory structure for the pdf submission format, for TSEapplications only.

附录1描述了针对仅TSE申报所建议的PDF申报格式文件/目录结构。

An application shouldcontain 3 modules as described below:

一份申报资料应包括3个模块，描述如下：

In Module 1:在模块1中：

-        Coverletter

-        封面函

-         EDQMApplication Form including signed declarations (as relevant)

-         EDQM申报表，包括签字声明（如相关）

-         Informationabout the Expert, CV as relevant (for a new application)

-         专家资料、CV（如相关）（新申报）

-        Responses: when responding to anEDQM deficiency letter, applicants should include a document/file listing thequestions with the corresponding responses and supportive data.

-        回复：如果是回复给EDQM缺陷函，申报人应包括一份文件列出问题及相应回复和支持性数据。

-            Additionaldata: asection/folder which may contain if relevant a toxicological report, a signedcopy of a CEP, etc.

-        其它数据：某个部分/文件夹，其中可以包括相关毒性报告、一份签字的CEP副本等

-        Revisions: a completed comparativetable (annex 7 to the application form) outlining the approved and proposedupdated text of module 3.

-        修订：一份完整的对比表（申报表附录7），列出模块3中已批准的和拟更新的内容。

In Module 2 (new CEP applications):在模块2中（新的CEP申报）：

-         QualityOverall Summary, prepared preferably using the EDQM template (the “Word” filetemplate should be converted into a pdf file).

-         质量综述，最好使用EDQM的模块起草（要将WORD文件模板转成PDF文件）。

In Module 3:在模块3中

-         For a new CEP application: technical documentationstructured in accordance with the CTD as defined by ICH guidance documents.

-         新CEP申报：技术文件按ICH指南文件中指定的CTD结构制作

-         Splittingthe data between an Applicant’s and a Restricted part is not encouraged for CEPapplications, but if these are submitted, the EMA “Practical guidelines on theuse of the eCTD format for ASMFs for Active Substance Master File Holders andMarketing Authorisation Holders” should be used as a basis; the CTD sectionsshould be clearly identified with the part they belong to.

-         不鼓励将CEP申报资料拆分为保密部分和公开部分，但如果拆分提交，则应采用EMA“ASMF持有人和上市许可持有人的ASMF使用eCTD格式实操指南”作为基础。应清楚定义每个CTD部分的归属。

-         Theuse of annexes/attachments is not allowed in Module 3.

-         在模块3中不允许使用附录/附件。

-         For a response to an EDQMdeficiency letter,or for a notification/revision/renewalapplication, the module 3 should be updated as described under section 5.Updated sections should be in line with the granularitychosen in the initial submission.

-         给EDQM缺陷信的回复或通知/修订/更新申报：模块3应按第5部分所述进行更新。更新后的部分应与初始申报中所选的分层保持一致。

-         Anychanges to a previous sequence should be highlighted and shall allow printing.

-         应着重显示对之前序列的所有修改，并应允许打印。  

5.  Lifecyclemanagement of applications申报资料的生命周期管理

Forthe lifecycle of a CEP application, it is necessary to have at any time acurrent view of the approved dossier, and to maintain an appropriate granularity.Applicants are requested to implement the following requirements, which will bechecked at receipt at EDQM.

在CEP申报的生命周期中，有必要在任何时候都有一份已批准文档的当前视图，并保持适当的分层。申报人应执行以下要求， EDQM在接收时会执行相关检查。

5 .1 Granularity层级

Large sections should be subdividedinto smaller parts. For example, the CTD sections 3.2.S.2,and 3.2.S.4 should besubdivided into subsections according to annex 2. It is important that the dossier can beeasily navigated. The addition of too many subsections to Module 3 can resultin the dossier being difficult to navigate and may result in blocking atreceipt, thus delaying its treatment.

较大的部分应拆分为更小的部分。例如，CTD部分3.2.S.2和3.2.S.4应依据附录2拆分为子部分。文档易于导航是很重要的。在模块3中增加太多子部分可能会导致文档难以查找，可能就会导致接收障碍，从而延迟对其处理。

5.2     Updatedsections更新后的部分

Anyupdate of a CEP application (eg. response to EDQM deficiency letters orrequests for revision) should include the related updated sections and thelevel of granularity of the data submitted should be in line with the levelchosen in the last procedure (see annex 2). Updated pagesonly are not accepted (except if the complete CTD section is on one page).

一份CEP申报资料的所有更新（例如，对EDQM缺陷信的回复，或申请修订）均应包括相关的更新后的部分，并且所提交数据的分层应与上次程序所选的层级相同（参见附录2）。不接受只提交更新后的页（除非完整的CTD部分就是只有一页）。

For each update of the dossier andwhatever the submission format, the following instructions should beimplemented:

对于文档中的每个更新，不管申报格式是什么，都要执行以下要求：

-  Responsesto an EDQM deficiency letter: Module 1 and 3 should be updated. Module 1 shouldcontain the responses to the questions and supportive data; in Module 3 thecomplete updated sections affected by the Questions & Answer process shouldbe included (with the changes highlighted if applicable).

- 对EDQM缺陷信的回复：模块1和模块3均应更新。模块1应包括对问题的回复和支持性数据；模块3中应包括受问答影响的完整更新后的部分（适用时应着重显示修改内容）。

-  Notificationsor requests for revision/renewal: Module 1 and 3 should be updated. All sections fromModule 3 affected by the proposed change(s) at the relevant granularity levelshould be updated and the changes highlighted. A comparative table of theapproved & proposed data should be given in Module 1.

- 修订/更新通知或申请：模块1和模块3均应更新。模块3中所有受拟定变更影响的部分均应按相关层级更新，并着重显示修改内容。在模块1中提交一份已批准VS拟定数据对照表。

Specific instructions applyalso, depending on the submission format chosen:

具体要求依据申报格式不同还适用于：

-        Foran eCTD: foreach update a new sequence 000(X+1) should be provided containing Modules 1, 3as appropriate, with updated files in the relevant sections, using the samestructure and granularityas the original submission. The files should have the appropriateoperation attributes: “New”, “Replace”, “Delete”. The use of  the “Append” attribute should be avoidedsince it leads frequently to lifecycle difficulties.

-        对于eCTD：每个更新中，所提交的新序列000（X+1）均应包括模块1和3（适当时），并在相关部分包括更新的文件，同时保持与原始申报中的相同结构和分层。文件应有适当的操作属性：“新增”、“替代”、“删除”。应避免使用“附录”属性，因为它常常会导致生命周期维护困难。

-        For a NeeS: the Modules 1, 3 shouldbe provided as appropriate, with updated files in the relevant sections, usingthe same structure and granularityas the original submission, and with a table of content.

-        对于NeeS：应提交模块1和3，适当时，还要提交相关部分中更新后的文件，需使用原始申报中的相同结构和层级，同时提交一份目录表。

-        For a PDF: in Module 3, the updatedsections should be supplied in one single pdf file, and the bookmarks should bein line with the original granularity of the dossier.

-        对于PDF：在模块3中，更新后的部分应以单个PDF文件提交，书签应与文档的原始分层一致。

Onlythe necessary updated information should be sent, and no other changes to thecontent of the dossier should be introduced. Failure to submit a completedocumentationset in the appropriate modules and sections will block the assessment processand may ultimately lead to blocking or rejecting the application at receipt.

只需要发送更新后的资料，不应引入对文档内容的其它修改。未能提交适当模块和部分中完整的系列文件将会对评审流程形成障碍，可能最后导致申报资料在接收时被阻或拒收。

5.3     Whento submit a baseline Module 3? 何时提交基准模块3？

Anelectronic “baseline” Module 3 is a consolidated picture of all the CTDsections corresponding to the regulatory information that has already beensubmitted and approved. If no baseline has been submitted so far, applicantsare strongly encouraged to submit a baseline application to EDQM to facilitatethe management of its lifecycle for both the applicants and the EDQM.

电子“基准”模块3是所有CTD部分的整合，它对应的是已经提交并批准的注册资料。如果截止目前尚未提交基准，强烈建议申报人提交一份基准申报给EDQM以便于申报人和EDQM对其进行生命周期管理。

It is strongly recommended to submit abaseline Module 3 in the following circumstances:

强烈建议在以下情形下提交模块3基准模块：

-        Switchfrom a paper to an e-submission

-        从纸质转为电子申报

-        Switchfrom a pdf/NeeS to an eCTD

-        从PDF/NeeS转为eCTD

Itis strongly recommended to submit a baseline Module 3 at the time of a renewal,a revision or a notification.

强烈建议在更新、修订或通知时提交基准模块3。

Onthe other hand a baseline Module 3will not be accepted duringthe course of a procedure (e.g. when responding to a deficiency letter or anyother information requested), nor when it is not linked to a regulatoryactivity (revision/renewal/notification).

另一方面，不接受在程序期间提交基准模块3（例如，在回复缺陷信时或要求提交其它信息时），也不接受没有法规活动时提交（修订/更新/通知）。

6.  Validationby the EDQM  EDQM执行的验证

Atreceipt of a submission by EDQM, a validation step is performed. Validationincludes verification of the submission format, compliance with therequirements described in this guidance document and in EU validation rules forNeeS and eCTD. The most frequent issues which may lead to block a dossier atreceipt and consequently delay the start of assessment are summarised in Annex 5.

EDQM收到申报资料时，会执行一个验证步骤。验证包括核对申报格式，核对是否符合本指南文件和NeeS与eCTD的EU验证规则中所述的要求。附录5中总结了可能会导致文档在接受时受阻从而导致审评开始延迟的最常见问题。

7.  Routes(or pathways) of submission申报提交途径（通道）

Electronic submissions should be submittedthrough the “Common European Submission Portal” (CESP). Users shouldfirst register with the CESP (https://cespportal.hma.eu) before sendingsubmissions to the EDQM.

电子申报资料应通过“欧洲通用申报端口”（CESP）提交。用户应先在CESP注册（https://cespportal.hma.eu）再将资料通过该端口发送至EDQM。

8.   Security安全

The files submitted should not haveany password protection, encryption or other security settings; such files willnot be accepted at the validation phase at EDQM. The applicant should check anyelectronic submission for absence of virus before sending it to EDQM.

所提交的文件不应有任何密码保护、加密或其它安全设置。此类文件在EDQM接收验证时无法接受。申报人在发送电子申报资料给EDQM之前应检查确保无病毒。

TheEDQM guarantees the security and confidentiality of data from receipt.

EDQM保证接收数据的安全性和机密性。

9.  Annexes:附录

英文原文官网链接 https://www.edqm.eu/sites/default/files/guidance_for_esubmissions_for_cep_applications-january2018.pdf

申报表也有相应修改，表1为新申报，表2为修订/更新

申报表1链接https://www.edqm.eu/sites/default/files/application-form-new-applicant-cep-form055.doc

申报表2链接 https://www.edqm.eu/sites/default/files/application-form-revision-renewal-cep-form056.doc

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