Before submitting an eCTD to EDQM, it should be technically validated using an appropriate checker/validation tool. If pass/fail errors are detected during 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 submission 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
— http://esubmission.ema.europa.eu/doc/
The CTD file/directory structure and naming shall be implemented with the 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 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 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 (See 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 Module 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 accordingly (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 and the submission should contain a table of content separating information related to each module 1, 2 and 3. An appropriate granularity should be included in module 3 (refer to annex 2).
要求的结构与PDF格式相同（参见附件5），模块1、2和3需要分开。应采用CTD结构，申报文件应包括一个目录，将与模块1、2和3中的信息区分开。在模块3中，应包括一个适当分层的标题（参见附件2）。
The paper submission should have appropriate quality to allow the scanning process (in particular graphs and chromatograms); otherwise the submission may be rejected.
所用的纸应具有适当的品质，以保证能进行扫描（特别是图表和色谱图），否则申报可能会被拒收。
For the content of the submission refer to the section 5.
申报文件内容参见第5部分。
CEP applications for the TSE risk TSE风险CEP申请
Applicants are invited to separate the documents and adapt the directory structure/document naming as proposed in annex 1.
希望申请人将文件拆开，采用附件1中提议的目录结构和文件命名
CEP applications for products for veterinary use only仅兽用CEP申请和产品
Applicants are invited to separate the documents and adapt the directory structure/document naming as proposed in annex 5.
希望申请人将文件拆开，采用附件5中提议的目录结构和文件命名
5
Content and structure of an application
申报的内容和结构
Annexes 3 and 4 describe how to structure a CEP application in eCTD or NeeS submission formats.
附件3和附件4描述了在eCTD或NeeS提交格式中应如何对CEP申请排布结构
Annex 5 describes the recommended file/directory structure for the pdf submission format and similarly for the paper submission format.
附件5描述了PDF提交和类似的纸质申请格式下推荐的文件/目录结构
An application should contain 3 modules as described below:
申请应包括下述3个模块
In Module 1: 模块1
— Cover letter 封面函
— EDQM Application Form including signed declarations (as relevant)
— EDQM申请表，包括签字申明（相关申明）
— Information about the Expert, CV as relevant (for a new application)
— 相关专家信息，简历（新申请需要）
— Responses: when responding to an EDQM deficiency letter, applicants should include a document/file listing the questions with the corresponding responses and
supportive data.
— 回复：如果是对EDQM的缺陷信的回复，申请人应包括一份文件，其中列明所回复的问题和相应的支持性数据
— Additional data: a section/folder which may contain if relevant a toxicological report, a signed copy of a CEP, …
— 其它数据：一个部分/文件夹可能需要包括相应的毒性报告，签字的CEP复印件等
— Revisions: a completed comparative table outlining the approved and proposed updated text of module 3. — 修订：一份完整的比较表格，其中列出模块3中已批准的内容和变更后的内容
In Module 2: 模块2
— Quality Overall Summary, prepared preferably using the EDQM template (the ―Word‖ file template should be converted into a pdf file in case of electronic submissions).
— 质量总结，最好采用EDQM模板（如采用电子提交，则―WORD‖格式应转换成为PDF文件）
In Module 3: 模块3
— For a new CEP application: technical documentation structured in accordance with the CTD as defined by ICH guidance documents.
— 新CEP申请：技术文件，文件结构符合ICH指南文件中CTD要求
— Splitting the data between an Applicant’s and a Restricted part is not encouraged for CEP applications, but if these are submitted, the EMA ―Practical guidelines on the
use of the eCTD format for ASMFs for Active Substance Master File Holders and Marketing Authorisation Holder‖ should be used as a basis; the CTD sections should be clearly identified with the part they belong to.
— 不鼓励将CEP申请分为保密部分和公开部分。但如果申请人按此提交，则应基于EMA―活性物质主文件持有人和上市许可持有人关于eCTD格式在ASMF中应用的规范
指南‖，CTD各部分应清楚标明其属于保密部分还是公开部分
— For a response to an EDQM deficiency letter, or for a notification/revision/renewal application, the module 3 should be updated as described under section 6. Updated
sections should be in line with the granularity chosen in the initial submission.
— 如果是对EDQM缺陷信的回复，或是通知、修订、更新申请，模块3需要如第6部分所描述进行更新。更新部分应与初始申报时选择的章节分类保持一致。
— Any changes to a previous sequence should be highlighted and shall allow printing.
— 对之前序列所做的任何变更均应高亮显示，并使其在打印时可见。
6
Lifecycle management of applications
申报的生命周期管理
For the lifecycle of a CEP application, it is necessary to have at any time a current view of the approved dossier, and to maintain an appropriate granularity. Applicants are requested to implement the following requirements, which will be checked at receipt at EDQM.
为了保证CEP申报的生命周期管理，需要保证所有批准文件都是现行的，并保持适当的分层标准。申请人应保证文件符合以下要求，EDQM在接收文件时将会对其检查。
Granularity: subdivision into small parts of a larger entity. For example, the CTD section 3.2.S.3. could be subdivided into 2 subsections (3.2.S.3.1, 3.2.S.3.2), which can each be subdivided into subsections (3.2.S.3.2.1, 3.2.S.3.2.2,…)
分层标题：对一个较大的部分，可以分成几个小部分。例如，CTD的第3.2.S.3部分可能分被细分为2个子部分（3.2.S.3.1, 3.2.S.3.2），而每个子部分又可以被细分为更小的部分（3.2.S.3.2.1, 3.2.S.3.2.2,…）。
6.1 Granularity and updated sections 章节分类和更新部分
Any update of a CEP application (e.g. response to EDQM deficiency letters or requests for revision) should include the related updated sections and the level of granularity of the data submitted should be in line with the level chosen in the last procedure (see annex 2 for the levels of granularity). Updated pages only are not accepted (except if the complete CTD section is on one page).
对于CEP申请的所有更新（例如，对EDQM缺陷信的回复或修订申请）均应包括相关更新部分，数据提交采用的层次分类应与之前所用的层次相同（见附件3分层）。仅对受影响页进行更新是不被接受的（除非完整的CTD部分仅包括一页）。
The use of annexes is not encouraged. 不鼓励使用附件
For each update of the dossier and whatever the submission format, the following instructions should be implemented:
每次文件更新时，不管是什么格式，应遵守以下要求
— Responses to an EDQM deficiency letter: Module 1 and 3 should be updated. Module 1 should contain the responses to the questions and supportive data; in Module 3
the complete updated sections affected by the Questions & Answer process should be included (with the changes highlighted if applicable).
— 对EDQM缺陷信的回复：需要更新模块1和模块3。模块1应包括对所有问题的回复和支持性数据；模块3应包括所有受到问答影响的更新部分（变更部分应高亮显示）
— Notifications or requests for revisions/renewal: Module 1 and 3 should be updated. All section form Module 3 affected by the proposed change(s) at the relevant
granularity level should be updated and the changes highlighted. A comparative table of the approved & proposed data should be given in Module 1.
— 修订/更新通知或申请：需更新模块1和模块3。模块3的所有受提交变更影响的部分，均应对相应的分层次部分进行更新，所有变更均应高亮显示。在模块1中，需要
给出已批准内容与变更后内容的对照表。
Specific instructions apply also, depending ton the submission format chosen:
根据提交格式不同，还有一些不同的要求
— For an eCTD: for each update a new sequence 0000 (X+1) should be provided containing Modules 1, 3 as appropriate, with updated files in the relevant sections,
using the same structure and granularity as the original submission. The files should have the appropriate operation attribute: ―New’, ―Replace‖, ―Delete‖, ―Append‖. The use of the ―Replace‖ attribute should be used rather than the ―Append‖ attribute. The use of the ―Append‖ attribute should be avoided since it leads frequently to lifecycle difficulties. The ―Append‖ may only be used when new information should be annexed to a section.
— 对于eCTD：每次更新时，应提交一个新的序列号，文件中应包括模块1和3（适用时）相关更新部分，其结构和分层标题应与初始申报一致。文件应具有适当的操作属
性―新增‖―替换‖―删除‖―附加‖。应尽量采用―替换‖，而少用―附加‖。应避免使用―附加‖属性，因为它会导致生命周期维护困难。仅当有新的信息需要附入某部分时，才应考虑使用―附加‖属性。
— For a NeeS: the Modules 1, 3 should be provided as appropriate, with updated files in the relevant sections, using the same structure and granularity as the original
submission, and with a table of content.
— 对于NeeS：应提供模块1，3，相应部分应更新，采用的层次应与原始提交一致，并与目录一致。
— For a PDF: in Module 3, the updated sections should be supplied in one single pdf file, and the bookmarks should be in line with the orgianl granularity of the dossier.
— 对于PDF：模块3中更新部分应以单个PDF文件提交，书签应与原始提交文件中层次一致。
— For a Paper submission: in Module 3, the updated sections should be supplied, respecting the granularity (refer to the annex 2). Even if a unique page is updated in a
CTD section, the full updated section should be provided in accordance with the granularity initially chosen.
— 对于纸质提交：应根据分层标题提交模块3中更新部分（参见附件2）。即使是更新CTD部分中某一单独页，仍需按初始提交所采用的层次标题提交完整部分。
Only the necessary updated information should be sent, and no other changes to the content of the dossier should be introduced. Failure to submit a complete documentation set in the appropriate modules and sections will block the assessment process and may ultimately lead to the rejection of the application at receipt.
只需要提交所需的更新部分，不应该对文件其它内容有任何更改。如未能提交适当模块中的完整文件部分，则评审过程会被阻止，可能导致最终申报被拒收。
6.2 When to submit a baseline Module 3? 什么时候提交基准模块3
An electronic ―baseline‖ Module 3 is a consolidated picture of all the CTD sections corresponding to the regulatory information that has already been submitted and approved. Applicants are encouraged to submit a baseline application to EDQM to facilitate the management of its lifecycle for both the applicant and the EDQM.
电子―基准‖模块3是一个固定的图片，包括CTD所有与法规信息相关的，已提交并批准的部分。鼓励申请人向EDQM提交基准申报资料，以便申请人和EDQM在其生命周期间进行管理。
It is mandatory to submit a baseline Module 3 in the following circumstances:
在以下情况下，并非必须提交基准模块3
— Switch from a paper to an e-submission 从纸质提交转换为电子提交
— Switch from a pdf/NeeS to an eCTD 从PDF/NeeS提交转换为eCTD提交
Unless an eCTD has already been submitted, it is recommended to submit a baseline Module 3 at the time of a renewal, a revision or a notification.
除非eCTD申报资料已提交，否则推荐在CEP换版时、修订时或通知时提交基准模块3。
On the other hand a baseline Module 3 will not be accepted during the course of a procedure (eg. When responding to a deficiency letter or any other information requested), not when it is not linked to any submission;
另一方面，基准模块3在其它程序进行期间是不被接受的（例如正在回复EDQM缺陷信时，或要求提交其它信息时），当它未与任何申报相链接时不被接受。
7
Validation by the EDQM EDQM
验证
At receipt of a submission by EDQM, a validation step is performed. Validation includes verification of the submission format, compliance with the requirements described in this guidance document and in EU validation rules for NeeS and eCTD. The most frequent issues which may lead to block a dossier at receipt and consequently delay the start of assessment are summarized in Annex 6.
EDQM在收到申报资料后，会进行验证。验证包括确认申报资料格式、是否符合本指南文件及欧盟对NeeS 和eCTD验证规范的要求。最常见的，可能会导致申报资料在接收时即被阻止，导致延迟的问题在附件6中已做了总结。
8
Routes (or pathways) of submission
递交方式（途径）
One of the following routes of submission can be used to send a submission or communication relating to a CEP dossier:
可选用以下任何一种提交方式提交申报资料或沟通CEP文件相关事宜
— Carrier for paper, CD-ROM, DVD, USB stick: 纸质、CD-ROM、DVD、U盘速递
The submission should be identified (name of the company, name of the substance and dossier number if known). If the identification of the dossier is not clear, this may delay the clock start of the submission. Electronic devices such as CD-ROM may be accompanied by a paper cover letter, provided that the cover letter is also included in the electronic version.
申报资料需要进行标识（公司名称、物质名称、如知道时标识文件编号）。如果申报资料的标识不清楚，可能会使申报的时间表延后。可以与电子设备一起，例如CD-ROM附上一份已有电子版本的纸质封面函。
— EDQM secured Dropbox for electronic submissions up to 300MB EDQM安全DROPBOX电子提交容量300MB
Access codes are needed and can be obtained upon request at cep@edqm.eu. The modules should be zipped together and sent by the contact person appointed for the application using a unique upload; otherwise the submission cannot be accepted.
提交路径需要输入代码，可以向cep@edqm.eu 申请获得。所有模块需要压缩在一起，由指定联系人一次性上传，否则，该申报将不被接受。
If the size of the dossier does not allow a unique upload, then a CD-ROM, DVD or USB stick should be sent.
如果文件太大无法单次上传，则应采用CD\\ROM、DVD或U盘发送。
To improve the handling of a submission sent by the Dropbox, the CEP reference number (if known) and the relevant type of submission should be indicated. If necessary, a message can be prepared to give additional indications (for example when submitting grouped notifications/revisions).
为提高对经由DROPBOX提交的申请的处理效率，应标明CEP编号（如已知）和相关的提交类型。必要时，可以发送信息给出更多标记（例如如果提交一个组合通知或修订）
The EDQM is currently investigating other options for electronic submissions
EDQM目前正在探索其它电子提交途径的可能性。