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PA/PH/CEP (15) 35,1R CEP申报资料电子提交 2016-2020蓝图 （201603） Certification of Substances Division HB/CB PUBLIC DOCUMENT (LEVEL 1) PA/PH/CEP (15)35, 1R Strasbourg, March 2016 Certification of suitability to theMonographs of the European Pharmacopoeia Electronic submissions for CEPapplications Roadmap 2016-2020 CEP申报资料电子提交 2016-2020蓝图 Address: 7 Allée Kastner, CS 30026F-67081 Strasbourg (France) Tel: +33 (0) 3 88 41 30 30 – Fax: +33(0) 3 88 41 27 71 - e-mail: cep@edqm.eu
1. Introduction 概述 The EDQM is the organisation responsiblefor the procedure of Certification of Suitability to the monographs of theEuropean Pharmacopoeia (CEP), and therefore receives dossiers describing themanufacture 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 thesubmission of applications in electronic format since 2007 and has providedregularly updated guidance for preparing and submitting eSubmissions (EDQMGuidance for electronic and paper submissions for Certificates of Suitabilityapplications, 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 atdeveloping and improving the current processes for submission of electronicdata 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： ? Efficientand 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） ? Fullyelectronic processing without paper or any physical media ? 全面电子进程，无纸质或任何物理介质 ? Automationof data transfer and storage ? 数据自动转移和存贮 ? Alignmentwith practice in place in regulatory agencies for eSubmission of marketingauthorisation 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 2. Current situation 目前状态 Procedures for the electronic submissionof CEP applications have been in place since 2007. The number of eSubmissionshas increased regularly, however paper applications, which are still acceptedcurrently, 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, theEDQM has so far accepted several kinds of formats, pdf, NeeS [1] and eCTD, as described in the lastversion of the respective EDQM guideline. The majority of applications receivedare in pdf, which is the most basic electronic format. eCTD represent less than20% of the formats received, regardless of the kind of submission (newapplication 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 byapplicants. 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 toreach 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 | | | l Single format for submission of data: eCTD (except for TSE only submissions, and for submissions for substances for veterinary use only [2]). l For TSE only submission PDF continues to be standard format accepted. | | l 数据申报单一格式：eCTD（TSE单一申报，兽药专用物质申报除外） 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 | | 数据申报单一安全入口：CESP，或EDQM指定的其它专用端口 | | Implement eApplication form/upload of electronic information from Application form | | | | Consistent information, aligned with eCTD specification | | | Receipt and validation of data | Automation of data transfer and storage, reduction of manual handling and checks | | | | Full use of review tool for all kinds of applications | | |
4. Actions and Timetable 措施和时间表 This section describes the detailedactions and estimated timeframes for completion of these actions in order toachieve the objectives described above and which have an impact on thepreparation 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
Submission format and content 申报格式和内容 No further acceptance of paper submissions for all kinds of applications (including TSE only submissions) Require eCTD submissions for New applications (except for TSE only submissions and for submissions for substances for veterinary use only [3]). For TSE only submission PDF continues to be standard format accepted. 要求新申报采用eCTD提交（TSE单一申报以及兽药专用物质申报除外） TSE单一申报仍可接受PDF格式 Stop accepting PDF submissions for revisions and renewals. Therefore, all such submissions need to be in NeeS or eCTD format (except for TSE only submissions and for submissions for substances for veterinary use only.) For TSE only submissions PDF continues to be standard format accepted. 停止接收PDF修订和更新申报（TSE单一申报和兽药专用物质申报除外）。 对于TSE，只有PDF申报格式继续作为标准可接受格式。 Require eCTD submissions for all applications including requests for revisions and renewals (except for TSE only submissions and for submissions for substances for veterinary use only). For TSE only submission PDF continues to be standard format accepted. 所有申报要求采用eCTD格式提交，包括修订和更新（除TSE单一和兽药专用物质申报外） TSE单一申报仍可采用PDF格式提交 Submission media and mechanisms Stop the use of the Dropbox and CDs, and use only the CESP (or a dedicated EDQM portal) 停止使用DROPBOX和CD，仅使用CESP平台（或指定的EDQM专用端口）
[1] Non-eCTD electronic Submission(NeeS). 非eCTD格式的电子申报格式。 [2] For submissions for substances forveterinary use only, VNeeS (Veterinary Non-eCTD electronic Submission) isaccepted. [3] For submissions for substances forveterinary use only, VNeeS (Veterinary Non-eCTD electronic Submission) isaccepted.
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