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1、ICH技术指导原则概述ICHGuidelinesIntroduction国家食品药品监督管理局丁建华2009年12月12日，北京ICHBriefing•BirthofICH:April1990,inBrussels•Maintopicscovers:Safety,QualityandEfficacy•Regionsinvolved:Europe,Japan,USA•Purposes:toproduceharmonizedtechnicalguidelines,reduceduplication•Modeloffunction:dia
2、loguebetweenregulatoryauthoritiesandthepharmaceuticalindustry1ICHStructure•ICHSteeringCommittee:finaldecisionmakerforICHguideline•••6Parties-EUandEFPIA-MHLW(PMDA)andJPMA-FDAandPhRMAEWGIWG3Observers:WHO,EFTA,andCanada(representedbyHealthCanada).6RHIs:APEC,ASEAN,GCC,PAND
3、RH,SADCICHWorkingmechanism•Conceptpaperproposed,EWGformedforeachofthetopicofQ,SandE•A5-Stepsdecision-makingmodelacceptedfromguidelineinitiationtoimplementation,Step2draftguidelinesonwebforcommentstillStep4,finalguidelineapprovedbySteeringCommitteeasfinalStep5guidelines
4、•IWGestablishedforimplementation,Q&AonICHWebforeachguidelines•GCGestablished1999,ChinaSFDAfirstattendedOct.23,20092ICHmeetings•UsuallyinternalexpertsmeetingeachICHactivityforaweek,followedbyapublicmeetingforupdatesuntilICH6•ICHmeetinghostedbyUS,JAPAN,EUineachJuneandOct
5、.inashiftedmanner•FromJune,2007inJapan,thefirstregionalpublicmeetingforICHupdates•FromJune,2008inUS,thefirstRegulatoryForumandDRA（DrugRegulatoryAuthority）invitedasmembertoattendICHGCGdiscussionandlistentoothertopicsTheTechnicalDataTargetCommonTechnicalDataTheScientific
6、InformationwhichdemonstratesSafetyQualityEfficacyandmeetstheRegulatoryRequirementsinEU,JapanandtheUSA3ICHGuidelinesCodeSystem•Q=QualityGuidelines，Qualityassurance,Pharmaceuticaldevelopment,GMP•S=SafetyGuidelines-nonclinicaltesting•E=EfficacyGuidelines-Clinicaltesting•M
7、=Multidisciplinary-RegulatoryCommunications-MedicalDictionary-Electronictransmissionofdata-CommonTechnicalDocumentICHTechnicalGuidelines(total71)5Multidisciplinary10QualityTopics(38guidelines)guidelines9SafetyTopics(13guidelines)MQSE9EfficacyTopics(15guidelines)4ICHGui
8、delines:Quality•OverviewImpuritiesValidationPharma-copoeiasStabilityGMPBiotechSpecific-ationsPharmaceuticalDevelopmen
