| 11月份EDQM對CEP申請的電子遞交的路線圖進行了修訂（附原文節(jié)譯） |
1月份EDQM對CEP申請的電子遞交的路線圖進行了修訂，其中的關鍵信息總結如下：
新的CEP申請：從2018年1月1日起強制執(zhí)行eCTD。較之前發(fā)布指南規(guī)定的2017年1月1日推后了1年。
變更和續(xù)證：2018年1月起，不再接受PDF格式的電子遞交，只能采取eCTD或者是NeeS格式。
2020年1月以后，所有的遞交（新申請，變更和換證）都必須采用eCTD格式。但是不包括TSE申請，TSE申請仍可使用PDF格式。
2017年1月以后，不再接受Dropbox和CDs的遞交方式。只能使用CESP通道。
【原文】
Electronicsubmissions for CEP applications
Revised Roadmap 2016-2020
1.Introduction 介紹
TheEDQM is the organisation responsible for the procedure of Certification ofSuitability to the monographs of the European Pharmacopoeia (CEP), andtherefore receives dossiers describing the manufacture and quality control ofsubstances for pharmaceutical use.
TheEDQM has been encouraging the submission of applications in electronic formatsince 2007 and has provided regularly updated guidance for preparing andsubmitting eSubmissions (EDQM Guidance for electronic and paper submissions forCertificates of Suitability applications, PA/PH/CEP (09) 108).
ThiseSubmission Roadmap aims at developing and improving the current processes forsubmission of electronic data related to CEP applications. The main goals areto have:
Efficient and secure electronic handling of data related to CEP applications(submission, reception, validation, processing)
Fully electronic processing without paper or any physical media
Automation of data transfer and storage
Alignment with practice in place in regulatory agencies for eSubmission ofmarketing authorisation applications.
TheRoadmap has been revised to align with the European procedures.
2.Current situation 現(xiàn)狀
Proceduresfor the electronic submission of CEP applications have been in place since2007. The number of eSubmissions has increased regularly, however paperapplications, which are still accepted currently, represent about 10% ofapplications received.
Withregards electronic formats, the EDQM has so far accepted several kinds offormats, pdf, NeeS1and eCTD, as described in the last version ofthe respective EDQM guideline. The majority of applications received are inpdf, which is the most basic electronic format. eCTD represent less than 20% ofthe formats received, regardless of the kind of submission (new application orrevision).
TheEDQM has decided to use the CESP (Common Electronic Submission Platform) as thepreferred way to receive eSubmissions. However, currently the Dropbox remainsthe transfer system most used by applicants.
3.Goals 目標
Thissection describes the objectives to reach within the next years.
Topic
Objectives
Submission format
Single format for submission of data: eCTD (except for TSE only submissions and for submissions for substances for veterinary use only2).
For TSE only submissions, PDF continues to be standard format accepted.
Submission media and mechanisms
Single and secure entry point for eSubmission of data: CESP, or alternatively an EDQM dedicated portal
Application form
Implement eApplication form/upload of electronic information from Application form
Content
Consistent information, aligned with eCTD specification
Receipt and validation of data
Automation of data transfer and storage, reduction of manual handling and checks
Use by assessors
Full use of review tool for all kinds of applications
4.Actions and Timetable 行動和時間表
Thissection describes the detailed actions and estimated timeframes for completionof these actions in order to achieve the objectives described above and whichhave an impact on the preparation of the submissions by applicants.
Topic
Timeframe
Actions
Submission format and content
June 2016
No further acceptance of paper submissions for any kind of application (including TSE only submissions)
January 2018
Require eCTD submissions for new applications (except for TSE only submissions and for submissions for substances for veterinary use only3).
For TSE only submissions PDF continues to be standard format accepted.
January 2018
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 only3).
For TSE only submissions PDF continues to be standard format accepted.
January 2020
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 only3).
For TSE only submissions PDF continues to be standard format accepted.
Submission media and mechanisms
January 2017
Stop the use of the Dropbox and CDs, and use only the CESP (Common European Submission Portal)
主題
時間點
活動
遞交格式和內(nèi)容
2016年6月
不再接受任何紙質格式遞交（包括TSE申請）
2018年1月
新的申請強制要求eCTD格式（不包括單獨的TSE申請和僅作為獸用的物質申請）
單獨的TSE申請，標準的申報格式仍為PDF格式。
僅作為獸用的物質申請，可接受的格式為VNeeS格式。
2018年1月
變更和續(xù)證不再接受PDF格式。因此所有的此類申請需要采用NeeS或者eCTD格式。（不包括單獨的TSE申請和僅作為獸用的物質申請）單獨的TSE申請，標準的申報格式仍為PDF格式。
僅作為獸用的物質申請，可接受的格式為VNeeS格式。
2020年1月
所有的遞交（新申請，變更和換證）都必須采用eCTD格式。（不包括單獨的TSE申請和僅作為獸用的物質申請）
單獨的TSE申請，標準的申報格式仍為PDF格式。
僅作為獸用的物質申請，可接受的格式為VNeeS格式。
遞交媒介和機制
2017年1月
不再接受Dropbox通道和CDs方式的遞交。
只接受CESP通道的遞交方式。
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