-
201306 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：
/en/?mbID=107
<
/p>
新版本生效日期：
2013
年
8
月
1
日
Certification of
Substances Division
FK/CB
PUBLIC DOCUMENT
公开文件
(LEVEL 1)
第一层次
English
only/Anglais seulement
仅英文版
Certification of suitability to
Monographs of the European
Pharmacopoeia
Guidance for
electronic and paper submissions
For Certificates of Suitability (CEP)
applications
CEP
电子和纸质申报指南
Date of implementation: 1 August 2013
Address: 7, sllee Kastner, CS 30026
F-67081 Strasbourg (France)
Telephone: 33(0)3 88 41 30 30
–
Fax: 33 (0) 3 88 41 27 71
–
e-mail:
cep@
Internet:
PA/PH/CEP(09)108,
2R
Strasbourg, June 2013
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
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
3
7
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 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 not 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
electronic 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 from 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
< br>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 (only 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 Module 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.
< br>这适用于所有类型的申报和信息交流。在
CEP
申请表格
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 the
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，
< br>文件夹和文件命名应采用
ICH M2 eCTD
指南，
和欧盟模块
1
标准。
< br>其它类型文件将不被接受
（
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 containi
ng 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 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<
/p>
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 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
/tiges/
) may be used for
such products.
单个
PDF
< br>文件（见附件
5
）或
NeeS<
/p>
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 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
—
—
/eCET/
It should
be clarified that the eCTD CEP dossier remains,
from a technical perspective,
a
standalone dossier and is distinct from any
marketing authorization 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
Eu-
envelope
欧盟
-
信封
Envelope
信封
Attribute
属性
Description/Instructions
描述
/
要求
Country
国家
ema
Submission
申报
Type
Active
Substance Master File (asmf)
类型
Mode
模式
Number
编号
Tracking
number
追踪号
Applicant
申报人
Agency
官方
Code
代码
Procedure
程序
Type
类型
Invented-
name
创建名
Inn
Sequence
序列号
Submission-
description
提交描述
活性物质主文件（
asmf
）
Blank
空白
Blank
空白
Blank except if
CEP application number known
空白除非已知
CEP
申请号
Holder/Intended
Holder name for the CEP
CEP<
/p>
持有人
/
意向持有人名称
EU-EMA
Use “centralized”
采用“集成”
Substance
name
物质名称
Refer to the EU Module 1
specification.
索引至欧盟模块
1
标准
Blank
空白
Certificate of
suitability/EDQM
CEP/EDQM
When
submitting the first eCTD submission, an initial
sequence 0000 should be provided. For 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 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
n
eeded,
especially when
responding to an EDQM deficiency letter (responses
to questions and supportive data).
如果是从
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<
/p>
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 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:
Nee
S
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
—
/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
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<
/p>
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.
< br>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<
/p>
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<
/p>
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<
/p>
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）
< br>
—
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
A
SMFs 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.
< br>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<
/p>
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<
/p>
CEP
申请的所有更新（例如，对
EDQ
M
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）。