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1、UpdateontheEuropeanPharmacopoeiaDr.SusanneKeitelWorkshoponGMP/Pharmacopoeia/APIBeijing,11-12July20121欧洲药典的更新SusanneKeitel博士GMP/药典/API研讨会北京,11-12July20122107Agenda•TheEDQMandthePh.Eur.•Generalworkingprinciples•Controlofimpurities•Heavymetals•P4procedure:asuccessstory•Ph.Eur.and“QualitybyDesign”•Ph
2、.Eur.strategyinthebiologicalfield•Ph.Eur.andadulterants©2012EDQM,CouncilofEurope,Allrightsreserved3日程•EDQM及欧洲药典•工作通则•杂质控制•重金属•P4规程：一个成功的故事•欧洲药典和“质量源于设计”•生物领域内的欧洲药典策略•欧洲药典和掺杂物©2012EDQM,CouncilofEurope,Allrightsreserved4108TheCouncilofEurope–Foundedin1949–DevelopmentofEuropeancommonanddemocraticpri
3、nciples–47membercountries–HeadquartersinStrasbourg–Corevalues:–protectionofhumanrights–pluralistdemocracy&theruleoflaw©2012EDQM,CouncilofEurope,Allrightsreserved5欧洲理事会–建于1949年–欧洲共同和民主原则的发展–47个成员国–总部位于斯特拉斯堡–核心价值：–人权保护–多元化民主&法制©2012EDQM,CouncilofEurope,Allrightsreserved6109EuropeanDirectorateforthe
4、QualityofMedicines&HealthCare(EDQM)•ACouncilofEuropeDirectorate,basedontheConventionontheElaborationofaEuropeanPharmacopoeia(PA,1964)•Mission:tocontributetoabasichumanright:accesstogoodqualitymedicinesandhealthcare©2012EDQM,CouncilofEurope,Allrightsreserved欧洲药品质量管理局（EDQM)•欧洲指导委员会，基于发展欧洲药典的共识(PA,1
5、964)•使命：为基本人权做贡献：良好药品和卫生保健质量©2012EDQM,CouncilofEurope,Allrightsreserved110EuropeanRegulatoryNetwork©2012EDQM,CouncilofEurope,Allrightsreserved欧洲立法网络©2012EDQM,CouncilofEurope,Allrightsreserved111EuropeanPharmacopoeia(Ph.Eur.)•Protectingpublichealth-onecommoncompulsorystandard•ThePh.Eur.istheoffici
6、alpharmacopoeiainEurope–complementedbynationalpharmacopoeiasfortextsofinteresttoonlyoneMemberState•Mandatoryatthesamedatein36MemberStates(CoE)andtheEU(decisionofPh.Eur.Commission).•LegallybindingqualitystandardsforALLmedicinalproductsinitsmemberstates,i.e.rawmaterial,preparations,dosageforms,cont
7、ainersmustcomplywiththePh.Eur.requirementswhentheyexist.©2012EDQM,CouncilofEurope,Allrightsreserved11欧洲药典•保护公共健康：一种普遍的义务标准•欧洲药典是欧洲的正式官方药典–以各成员国的国家药典作为补充，该国家药典内容仅对该国有用•在36个成员国（欧洲委员会）和欧盟内同一天强制生效（欧洲药典委员会决策）.•对欧盟成员国内所有药品标准
