CEP申报资料电子提交 2016-2020蓝图草案

julia朱玉姣

Certification of Substances Division

HB/CB

PUBLIC DOCUMENT

(LEVEL 1)

PA/PH/CEP (15) 35

Strasbourg, September 2015

Certification of suitability to the Monographs of the European Pharmacopoeia

Public enquiry

公开调查

Electronic submissions for CEP applications

Draft Roadmap 2016-2020

CEP申报资料电子提交 2016-2020蓝图草案

Address: 7 Allée Kastner, CS 30026 F-67081 Strasbourg (France)

Tel: +33 (0) 3 88 41 30 30 – Fax: +33 (0) 3 88 41 27 71 - e-mail: cep@edqm.eu

Internet: http://www.edqm.eu

1. Introduction 概述

The EDQM is the organisation responsible for the procedure of Certification of Suitability to the monographs of the European Pharmacopoeia (CEP), and therefore receives dossiers describing the manufacture and quality control of substances for pharmaceutical use.

EDQM是负责CEP程序的机构，因此会收到描述药用物抽生产和质量控制的文档。

The EDQM has been encouraging the submission of applications in electronic format since 2007 and has provided regularly updated guidance for preparing and submitting eSubmissions (EDQM Guidance for electronic and paper submissions for Certificates of Suitability applications, PA/PH/CEP (09) 108).

自2007年以来，EDQM一直在鼓励申报人采用电子格式提交，并且定期提供更新指南指引如何采用电子方式准备和提交（EDQM电子和纸质申报CEP指南，PA/PH/CEP (09) 108）。

This eSubmission Roadmap aims at developing and improving the current processes for submission of electronic data related to CEP applications. The main goals are to have:

本电子申报蓝图目的是建立和促进现在的CEP相关电子数据提交流程。主要目标有：

•      Efficient and secure electronic handling of data related to CEP applications (submission, reception, validation, processing)

•      有效安全处理CEP申报资料有关的电子数据（提交、接收、验证、处理）

•      Fully electronic processing without paper or any physical media

•      全面电子进程，无纸质或任何物理介质

•      Automation of data transfer and storage

•      数据自动转移和存贮

•      Alignment with practice in place in regulatory agencies for eSubmission of marketing authorisation applications.

•      与现有法规官方对上市许可申报的电子提交要求规范保持一致

This Roadmap describes the current situation with regards eSubmission at EDQM as well as the objectives for the next 4 years and the actions required to achieve them.

本蓝图描述的是目前EDQM电子提交的状态，以及今后4年间的目标，和达成这些目标所需采取的措施。

Since this Roadmap represents a major change to current practices, the EDQM would like to gather comments from stakeholders on the actions and timelines, and if necessary review the plans before implementing them.

由于该蓝图代表了对目前做法的主要变化，EDQM希望收集干系人对措施和时间计划的意见，必要时在实施前对计划进行审核。

Comments may be sent to EDQM through Industry associations (by direct contact) or as individuals through the EDQM Helpdesk on the EDQM website (https://www.edqm.eu/en/EDQM-FAQ-and-Helpdesk-List-630.html).

建议可以通过行业协会（直接联系人）发送到EDQM，如果是个人的话，可以通过EDQM官网上述链接EDQM帮助桌面发送。

The deadline for comments is 31 December 2015.

建议收集截止日期为2015年12月31日。

2. Current situation 目前状态

Procedures for the electronic submission of CEP applications have been in place since 2007. The number of eSubmissions has increased regularly, however paper applications, which are still accepted currently, represent about 10% of applications received.

CEP申报的电子提交程序自2007年就已经开始使用了。电子提交的数量稳定增长，但是，目前仍可以接受纸质申报，所收到的申报中约有10%为纸质。

With regards electronic formats, the EDQM has so far accepted several kinds of formats, pdf, NeeS and eCTD, as described in the last version of the respective EDQM guideline. The majority of applications received are in pdf, which is the most basic electronic format. eCTD represent less than 20% of the formats received, regardless of the kind of submission (new application or revision).

关于电子格式，EDQM目前接受几种格式：PDF、NeeS和eCTD，如相应的EDQM指南上一版本所述。所收到的申报中大部分是PDF格式，这是最为基本的电子格式。eCTD在收到的各类（新申报和修订）申报中只占20%。

The EDQM has decided to use the CESP (Common Electronic Submission Platform) as the preferred way to receive eSubmissions. However, currently the Dropbox remains the transfer system most used by applicants.

EDMQ已决定采用CESP（通常电子提交平台）作为优选方式来接收电子申报资料。但是，现在申报人使用最多的还是DROPBOX。

3. Goals 目标

This section describes the objectives to reach within the next years.

本部分所述的是在之后几年中要达到的目标。

Topic 主题	Objectives 目标
Submission format	l  Single format for submission of data: eCTD (except for TSE only submissions). l  For TSE only submission PDF continues to be standard format accepted.
申报格式	l  数据申报单一格式：eCTD（TSE单一申报除外） l  TSE单一申报仍可继续采用PDF格式
Submission media and mechanisms	Single and secure entry point for eSubmission of data: CESP, or alternatively an EDQM dedicated portal
申报介质和机制	数据申报单一安全入口：CESP，或EDQM指定的其它专用端口
Application form	Implement eApplication form/upload of electronic information from Application form
申报表格	实施电子申报表格/申报表格中的电子信息上传
Content	Consistent information, aligned with eCTD specification
内容	一致的资料，与eCTD要求相同
Receipt and validation of data	Automation of data transfer and storage, reduction of manual handling and checks
数据接收和验证	自动数据转换和存贮，减少人工处理和检查
Use by assessors	Full use of review tool for all kinds of applications
审评员使用	所用类型申报全面使用审核工具

4. Actions and Timetable 措施和时间表

This section describes the detailed actions and estimated timeframes for completion of these actions in order to achieve the objectives described above and which have an impact on the preparation of the submissions by applicants.

本部分所述的是详细的措施，和为达成上述目标而需要完成这些对申报人资料准备产生影响的措施的预计时间表。

Topic 主题	Timeframe 时间表	Actions 措施
Submission format and content 申报格式和内容	June 2016	Stop accepting paper for all kinds of applications (including TSE only submissions)
	2016年6月	停止接收所有类型的纸质申报（包括TSE单一申报）
	January 2017	Require eCTD submissions for New applications (except for TSE only submissions). For TSE only submission PDF continues to be standard format accepted.
	2017年1月	要求新申报采用eCTD提交（TSE单一申报除外） TSE单一申报仍可接受PDF格式
	January 2017	Stop accepting PDF submissions for revisions (except for TSE only submissions where PDF continues to be standard format accepted.
	2017年1月	停止接收PDF修订申报（TSE单一申报除外，可以接受PDF格式）
	January 2020	Require eCTD submissions for all applications including requests for revisions and renewals (except for TSE only submissions). For TSE only submission PDF continues to be standard format accepted.
	2020年1月	所有申报要求采用eCTD格式提交，包括修订和更新（除TSE单一申报外） TSE单一申报仍可采用PDF格式提交
Submission media and mechanisms	January 2017	Eliminate the use of the Dropbox and CDs, and use only the CESP (or a dedicated EDQM portal)
申报介质和机制	2017年1月	停止使用DROPBOX和CD，仅使用CESP平台（或指定的EDQM专用端口）

卡卡乌斯

谢谢Julia老师！

lx0003

谢谢 分享         

道路漫长黑暗

好事，想起来打孔机下面那一坨坨的纸屑就头大。

syhorchid

谢谢分享

青青草芯

好好学习，谢谢分享

Dreaming

纸质申报CEP快终结了。