中国-欧盟药品质量相关法规研讨培训资料药典的协调

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1、Pharmacopoeialharmonisation…anindustryperspectiveDrStephenW.CookEC-ChinaHighLevelRegulatoryDialogueWorkshoponGMP/Pharmacopoeia/APIs11-12thJuly2012药典的协调…工业界展望中国-欧盟药品注册高层对话GMP/药典/APIs研讨会11-12thJuly2012/2012年7月11-12日144Introduction•Harmonisedpharmacopoeiahelptoensurepatientaccesstohighquality

2、medicinesandvaccinesworldwide•Aspartofthe2015ChPdevelopment,Industryrecognises;–Increasedopportunitytoprovidecommentsfor2015ChPrevisions–Greaterclarityonthedraftingprocedures–EngagementbyCPCwithotherpharmacopoeialbodies–Referencetootherpharmacopoeiasduringdraftingofmonographs•Industryencou

3、ragesthisdevelopmentandwouldliketoraiseseveralpointsfordiscussionIntroduction引言•协调药典有助于保证患者使用世界上的高质量药品和疫苗。•作为2015版中国药典发展的一部分，企业认识到：–提供2015版中国药典修订说明的机会增加；–起草规程更清晰；–CPC与其它药典机构的参与；–专论起草过程中参考其它药典。•行业支持这样发展，希望提出几点供讨论。145PointsofDiscussion1.Pharmacopoeialharmonisation2.Thelevelofdetailinthemonog

4、raphs3.Expertcommitteesandindustryinvolvement4.Considerationforproductdevelopment5.DocumentedprocessforreviewPointsofDiscussion讨论要点1.药典的协调2.专论的详细程度3.专家委员会和企业参与4.产品开发的考虑因素5.书面审查流程1461.PharmacopoeialharmonisationSomeobservations•Chinaisanincreasinglyimportantglobalplayer–Chinaisnowthefifthla

5、rgestpharmaceuticalmarketintheworld•Adoptionofhighandconsistentstandardsthroughharmonisedpharmacopoeiawillhelpensurethereliabilityoftheglobalsupplychain•AlignmentandharmonisationofpharmacopoeiasiscriticalformultinationalcompaniesseekingtosupplynewmedicinesintoChinaandforChinesemanufacturer

6、saimingtoexportproductsglobally.1.Pharmacopoeialharmonisation/药典的协调Someobservations/一些观测结果•中国是全球越来越重要的参与者–目前，中国是世界上第五大药品市场。•通过协调药典，采用高度一致的标准将有助于确保全球供应链的可靠性•药典的协调一致对寻求向中国供应新药的跨国公司和意在全球出口产品的中国生产商非常关键。147PharmacopoeialharmonisationWhyisthisimportant?•Differentstandardsmayleadtodifferentspecif

7、icationsandmanufacturingprocessesfordifferentcountries/populations–Exclusionofwidelyregisteredproducts(establishedQSE)fromaregion–Mayputavailabilityofkeyvaccinesandmedicinesatrisk•Complicatesaglobalsupplychain–differentmethodsofmanufacture&productspecification