CEP申报资料电子提交4年蓝图.pdf

Certification of Substances Division HB/CB PUBLIC DOCUMENT (LEVEL 1) PA/PH/CEP (15) 35, 1R Strasbourg, March 2016 Certification of suitability to the Monographs of the European Pharmacopoeia Electronic submissions for CEP applications Roadmap 2016-2020 CEP 申报资料电子提交 2016-2020 蓝图 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