每种事项又根据对药品安全性、有效性和质量可控性产生影响的潜在风险,分为三类:重大变更、中等变更、微小变更。而在EDQM递交CEP变更时主要参照的指南为《GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAP》(2018年9月更新,2019年1月实施)。该指南...
变更分类报告类变更(微小变更或其他)备案类变更(中等变更或其他)审评类变更(重大变更或其他)药典专论升级(结合国家局关于药典升级的通知及所在省份(如有)的相关通知判断属于报告类/备案类/审评类)与左同通知(annual notification)立即通知(immediate notification)微小(minor)重大(major)药典专论升级( monograph revisi...
Guideline On Requirements for Revision Or Renewal Of CEP-PA PH CEP(04) 2 4R 200912-CN(EDQM关于CEP修订或更新要求的指南--中英文) 热度: 一、欧洲药品质量管理局(EDQM)简介 随着加入WTO和世界经济一体化进程的加快,在药品贸易方面,国内企业逐步走出国门, ...
Guideline On Requirements for Revision Or Renewal Of CEP-PA PH CEP(04) 2 4R 200912-CN(EDQM关于CEP修订或更新要求的指南--中英文) 热度: ICH Q8 Q9 - Presentation for IPA-EDQM Workshop 热度: EDQM文件: PA/PH/CEP(04)14R(February2007) ...
The changes related to Ph. Eur. monograph revisions or any other regulatory requirements are treated separately and generally initiated by the EDQM.执行日期：2010年3月1日 介绍：欧洲药典适用性证书持有人必须向EDQM报告所有与申报文件有关的变更，申报时应填写申请表格和所有必要的资料，证明变更符合现行指南...
“Guideline on Requirements for Revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) )” and may include: - Changes to limits for elemental impurities in the final substance: addition/deletion/tightening/widening - Changes to the method(s) used...
All APIs identified to be at risk of presence of nitrosamines should be tested and the results provided to EDQM with, if needed, a proposal for subsequent actions (such as revision of the CEP). CEP holders should inf...
RevisionorRenewalofCertificatesofSuitabilityandapplicationsusingthe‘sisterfiles’ procedure(PA/PH/CEP(13)110,3R,November2021) 5©EDQM,CouncilofEurope,2023.Allrightsreserved. Timelinesforrevisionapplications RefertotheEDQMdocument: ManagementofapplicationsfornewCertificatesofSuitability,RequestsforRevisionorRenewalof...
Therefore if the referenced CEP X is revised then a copy of the revised CEP X must be submitted as a revision to the CEP Y, as described in the current version of the EDQM Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (...
斯特拉斯堡，2012年7月 Certification of Suitability toMonographs of the European Pharmacopoeia Guidance on frequent changes to applications for Certificates of Suitability (CEPs)欧洲药典适用性证书常见CEP变更申请指南 Address: 7 allée Kastner CS 30026 - F 67081 Strasbourg Telephone: 33 (0) 3 88 41 30...