主题：【原创】【第二届网络原创作品】CEPs证书电子申请的递交-翻译

Before submitting an e-CTD to EDQM, its sequence should be technically validated using appropriate checker tools.

For NEES dossiers, in order to ease navigation within each section, a separate table of content should also be created (Word document) with reasonable hyperlinks to the main sections of the modules.

It is still acceptable to provide a simple pdf file covering all sections of Module 3, provided the CTD requirements are met, the structure given in Annex 2 is implemented and full bookmarking of the sections is made. Separate files have to be submitted for module 1 and 2 in this case. This is applicable for a new submission or a request for revision/renewal.

一个e-CTD在递交给EDQM之前，它的顺序应该使用适当的检测工具进行技术验证。
对于NEES文件，为了使每一部分易于导航，对于模板的主要部分，应该建立一个合理超链接的单独的目录表格（Word文档）。

如果能符合CTD的要求，遵循了附件2中的结构，并且为每一章节制作了书签，那么，一个简洁的、涵盖了模块3所有章节的PDF文档仍是可以接受的。在这种情况下，模块1和2必须以单独的文件递交。对于一个新的递交或修订/更新的要求，这是可接受的。

••Structure of a new application:

In module 1:
-     EDQM application form including signed declarations
-     Cover letter
-     Answers to deficiency letters for the part related to Questions/Answers: this is a document addressing point by point the items of the deficiency letter sent by EDQM. Additionally, any answer to a deficiency letter should also include updated sections in module 3 as described below.

In module 2:
-     QOS, in Word format, and prepared using the EDQM template. Module 2 should also include the CV of the expert. There is no need to provide a signed document.

In module 3:
-     Technical documentation in accordance with the CTD format as defined by ICH guidance documents, and the format described in Annex 1 and 2
-     Any updated sections, which should have the appropriate operation attribute “New”, “Add”, “Replace”, “Delete”
-     Splitting the data between an applicant’s and a restricted part is not encouraged for CEP applications, but if they are submitted they should be included in the relevant sections, according to the structure given in the Annex, and identified as such.

••新申请的结构

在模块1中：
- EDQM申请表，包括已签名的声明
- 说明信
- 关于问/答部分的缺陷信回复：这是由EDQM发出的逐项回复的缺陷信文件。另外，缺陷信的回复内容也应该包括模块3中所描述的更新的部分。

在模块2中：
- QOS，按EDQM提供的模板，以Word格式进行准备。模块2也应该包括专家简历。不需要提供一份签名的文件。

在模块3中：
- 根据ICH指导文件中所指定的CTD格式准备的技术文件，其格式在附件1和2中被描述。
- 对于任何更新的部分，都应该以“新”、“增加”、“取代”、“删除”等适当的方式进行标志。
- 对于CEP申请，不鼓励将公开部分与保密部分资料分开，但是，如果他们被分开递交，根据附件中所给出的结构，他们应该包括在相关的章节中，并且要加以鉴别。

    •    Structure of a request for revision/renewal, or a notification:

In module 1:
-     EDQM application form including signed declarations when applicable
-     Cover letter describing the request for revision and including supportive data, comparative tables, etc, as required by the EDQM guidelines for revisions/renewals.
-     Answers to deficiency letters for the part related to Questions/Answers: this is a document addressing point by point the items of the deficiency letter sent by EDQM. Additionally, any answer to a deficiency letter should also include updated sections in module 3 as described below.

In module 2:
-     Generally an update of Module 2 is not required for revisions/renewals.

In module 3:
-     Technical documentation in accordance with the CTD format as defined by ICH guidance documents, and the format described in Annex 1 and 2. This should include the respective updated sections in module 3 affected by the changes
-     Any updated sections, which should have the appropriate operation attribute “New”, “Add”, “Replace”, “Delete”.

••修订/更新或通知要求的结构

在模块1中：
- EDQM申请表，适用的情况下包括已签名的声明
- 根据EDQM关于修订/更新的指导方针的要求，描述修订要求并包括支持性数据，比较表等的说明信
- 关于问/答部分的缺陷信回复：这是由EDQM发出的点对点回复的缺陷信文件。另外，缺陷信的回复内容也应该包括模块3中所描述的更新的部分。

在模块2中：
- 通常，对于修订/更新，模块2的更新是不需要的。

在模块3中：
- 根据ICH指导文件中所指定的CTD格式准备的技术文件，其格式在附件1和2中被描述。这应该包括模块3中受变更影响的各自更新的章节。
- 对于任何更新的部分，都应该以“新”、“增加”、“取代”、“删除”等适当的方式进行标志。

4. Lifecycle management

In the case of e-CTD or NEES, for each update of the dossier (which happens following a request for additional information or any request for revision), a new sequence 000(+1) should be provided containing module 1, and modules 2 and 3 as appropriate, with relevant updated files in the sections, using the same structure as originally.

The files should have appropriate “operation” attribute, i.e. relevant codification (“New”, “Add”, “Replace” or “Delete”). The cover letter should additionally describe the list of the updated sections and updated or added files of Module 3.

If a single pdf file is submitted for Module 3, for each update, the entire file should again be supplied in one PDF file including submitted changes and the respective amended chapters, and highlighting the modifications.

4. 生命周期的管理

在以e-CTD或NEES格式递交的情况下，对于每一个更新的文件（对于增加的信息或修订的任何要求），应该提供一个新的序列号，适当情况下包括模块1、2和3章节中相关的更新文件，使用与原文件相同的结构。
文件应该有适当的操作特征，也就是相应的汇编（“新”、“增加”、“取代”或“删除”）。说明信应该额外地描述更新章节的列表以及模块3中更新或增加的文件。
如果模块3以一个单独的pdf文件递交，则对于每一次更新，完整的文件应该以PDF文件再次递交，包括变更的递交以及各自修改的章节，并以高亮方式对所做出的修改进行突出显示。

5. Format of the electronic files

The files should be in Acrobat PDF, with the exception of:
-     the QOS, which should be a Word document prepared with the EDQM template
-     the letter of response to an EDQM deficiency letter, which should also be in Word format or at least in pdf with OCR (Optical Character Recognition), for the part addressing each point of the deficiency letter.

Requirements for PDF documents:
-     They have to be created from electronic source documents, and should have been checked for OCR.
-     Scanned images are acceptable only for pictures or diagrams (e.g. chromatograms, spectra,…), and not for the text.
-     The files should not be protected and should allow extraction/copy-paste.

No other files than PDF or Word documents are allowed.

5. 电子文件的格式

除了下述情况之外，文件应该是PDF格式：
- QOS，应该按EDQM提供的Word模板准备。
- EDQM缺陷信的回复，对于缺陷信的每一条也应该是Word格式或者至少带OCR的PDF格式。

PDF文件的要求：
- 他们必须以电子来源的文件被建立，并且必须对OCR进行检查。
- 仅仅图片或图示（如色谱图，光谱图等）以扫描图像格式是可接受的，并且不是针对正文。
- 文件不应该受保护并且应该可以选取/复制-粘贴。

•    File names

The file names should include at the beginning, and if known, the CEP dossier number, with the format YYYY-XXX (eg. 2009-001).

The file names should be allocated according to the CTD format as described in ICH guidance documents. Any update should also have the appropriate operation attribute (“New”, “Add”, “Replace”, “Delete”).

The applicant should use only letters, numbers or hyphens in the name of the file. Neither special characters nor blank spaces should be used.

••文件名

文件名应该包括开始的时间，如果知道CEP号则应该有CEP档案号，格式为YYY-XXX （如2009-001）。
文件名应该按ICH指导文件中所描述的CTD文件格式建立。任何更新也应该有适当的操作特征（“新”、“增加”、“取代”或“删除”）。
在文件名中申请者应该只使用字母，数字或连字号。不应该使用特殊的字母或空格。

6. Way of submission

The applicant can submit electronic files through the 3 ways described below:

-     CD-ROM or DVD properly identified, which should show the name of the company, the name of the substance and the dossier number if known
-     Internet secure Dropbox: for files up to 100 MB only. Access codes are needed and can be obtained upon request to cep@edqm.eu
-     E-mail addressed to cep@edqm.eu for letters only.

6. 递交方式

申请者可以通过以下三种方式递交电子文件：
- CD-ROM或DVD。应该显示公司名称，原料药名称以及文件号（如果知道的话）。
- 网上安全的Dropbox：文件大小的上限是100MB。需要登录密码，可以向cep@edqm.eu申请获得。
- 仅仅以信的方式发E-mail给cep@edqm.eu。

7. Security

The applicant should check the submission for absence of virus before sending it to EDQM. As for paper applications, EDQM guarantees the security and confidentiality of electronic data from the receipt, whatever route of submission is selected from the choices above.

7. 安全

文件发送给EDQM之前，申请者应该检查递交文件不含病毒。至于纸申请，无论选择的是什么递交方式，EDQM保证所收到电子资料的安全性与保密性。

8. Implementation

The requirements described in this document will allow EDQM to use electronic submissions efficiently.
Once a company has made an e-submission, failure to comply with these requirements may lead to the rejection of the submission and a complete new application may then have to be submitted.

8. 执行

这份文件所描述的要求将有利于EDQM有效地使用电子递交。一旦一个公司使用了电子递交，不符合这些要求的文件将导致文件的拒收并且需要递交一个新的完整的申请。

Annexes:
Annex 1: EDQM requirements concerning the granularity of eCTD or NEES
Annex 2: EDQM requirements concerning the granularity of single pdf file.

附件：

附件1：EDQM关于eCTD or NEES要求细则
附件2：EDQM关于单独PDF文件要求细则

说实话，很惭愧，很多英文我还看不懂。不过，支持你了。投你一票

Some suggestions:

Before submitting an e-CTD to EDQM, its sequence should be technically validated using appropriate checker tools.

一个e-CTD在递交给EDQM之前，它的顺序应该使用适当的检测工具进行技术培训验证。(培训should be deleted)

= = = = = =

对于NEES文件，为了使每一部分易于导航，对于模板的主要部分，应该建立一个合理超链接的单独的目录表格（Word文档）。

Table of content (TOC) = 目录  (表格 should be deleted)

= = = = = =

- Answers to deficiency letters for the part related to Questions/Answers: this is a document addressing point by point the items of the deficiency letter sent by EDQM.
- 关于问/答部分的缺陷信回复：这是由EDQM发出的点对点回复的缺陷信文件。

此乃逐项(point by point)回应(addressing)EDQM发出的缺陷信之文件

= = = = = =

- QOS，按EDQM提供的模板，以Word格式进行准备。模块2也应该包括专家简历。不需要提供一份单独的文件。  (In the original, the word is signed, not single)

= = = = = =

- Generally an update of Module 2 is not required for revisions/renewals.
- 通常, 对于修订/更新，模块2的完整更新是不需要的。 (完整should be deleted)

接受poorlittle专家的意见,我已经改过来了.有空时再帮忙改改哦

Some notes after reading the post at 2/F:

4. Lifecycle management

Cover letter : 说明信/说明函/封面函 (http://www.proz.com/kudoz/english_to_chinese/business_commerce_general/3158992-cover_letter.html), 亦有译作 “附信”(http://loco-loca.blogspot.com/2009/04/resume-coverletter.html) , In the submission, the main body is the submitted document, cover letter 译作 “附信”亦不无道理。  不知文秘介是怎样译这个词?

= = = = = =

which happens following a request for additional information or any request for revision : 源于对增加信息或修订的要求

= = = = = =

a new sequence 000(+1) should be provided : 应该提供一个新的序列号000(+1) . 000(+1) in the original should also appear in the translation (It seems to indicate that the sequence number should be in 3 digits with increment of 1, i.e. 008, 009, 010, 011; not 120, 130, 140)

= = = = = =

Highlighting : In Traditional Chinese version of Adobe Acrobat (the program for pdf file), highlighting is translated as 反白, while in Traditional Chinese version of WORD, it is translated as 醒目提示.  但楼主的翻译已很好。


5. Format of the electronic files

-        the letter of response to an EDQM deficiency letter, which should also be in Word format or at least in pdf with OCR (Optical Character Recognition), for the part addressing each point of the deficiency letter.

对EDQM缺陷信的回复应是Word格式。 若是PDF格式, 至少在回应缺陷信的部份, 处理成OCR(可兼容光学认字)

= = = = = =

- They have to be created from electronic source documents, and should have been checked for OCR.
意译 : 可兼容光学认字

= = = = = =

Scanned images are acceptable only for pictures or diagrams (e.g. chromatograms, spectra,…), and not for the text.

- 扫描图像格式仅(or 只能)用于图片或图示（如色谱图，光谱图等），不能用于文字。


= = = = = =

The file names should include at the beginning, and if known, the CEP dossier number, with the format YYYY-XXX (eg. 2009-001).

at the beginning = 左端?

If the CEP dossier number is ABC123, is the file name “AABC123-2009-001-New.doc” acceptable?

原文由 poorlittle 发表:

The file names should include at the beginning, and if known, the CEP dossier number, with the format YYYY-XXX (eg. 2009-001).

at the beginning = 左端?

If the CEP dossier number is ABC123, is the file name “AABC123-2009-001-New.doc” acceptable?

at the beginning在这里是不是“顶端”的意思？因为我们在实际操作中每一页的顶端都有文件名的显示

非常非常需要，非常非常好！感谢楼主！

原文由 hyheying 发表:

原文由 poorlittle 发表:

The file names should include at the beginning, and if known, the CEP dossier number, with the format YYYY-XXX (eg. 2009-001).

at the beginning = 左端?

If the CEP dossier number is ABC123, is the file name “AABC123-2009-001-New.doc” acceptable?

at the beginning在这里是不是“顶端”的意思？因为我们在实际操作中每一页的顶端都有文件名的显示

May be.  This should be interpreted with reference to the norm of this field.

= = = = = =

But, the phase “at the beginning” is under the sub-section “file names”;  furthermore, “每一页的顶端” is called Header (每一页的下端 is Footer).