ICH和欧盟药品风险管理指南简介

ChinJClinPharmacolVol125No12Mar12009(SerialNo1118)DrugEvaluationandAdministrationICHSummarizeofguidelinesondrugriskmanagementprogramsofICHandEMEA:2008-11-09:2009-02-04:(1976-),,,:Tel:[phone]E2mail:tangjy@cde1org1cn(,100038)TANGJian2yuan(CenterforDrugEvaluation,StateFoodandDrugAdministration,Beijing100038,China):,,,,,:;;:R954;R96913:C:1001-6821(2009)02-0177-03Abstract:Riskassessmentoccursthroughoutaproductslifecycle1Theaimofriskmanagementiscontinuouslytoimprovedrugapplicationsafe2ty1Wemayavoidsomeinappropriatemedicalactionsreasonablyifonlyef2fectivestudysondrugsafesignalandmethodsofriskmanagement1Withaseriesofnewdrugregistrationtechnicalrequirementspromulgatedintherecenttime,theagencywillasktheindustrytoresearchhowtominimizedrugsriskandtosubmitriskmanagementplanssoon1Maybewecangetsomeavailablesuggestionsfromtheforeignrelevantguidelines1Keywords:riskmanagement;pharmacovigilance;safety,,,,;,,,/;,,,/;,;/;,/,4,,1(InternationalConferenceonHarmonizationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse,ICH)E2E(PharmacovigilancePlanning)[1]77125220093(118),WHO()111(safetyspecification),,;,112:(/);(QT);;:;();(AEs)(ADRs);,--;;113,:,,;;,;,;;;;,:(passivesurveillance),(spontane2ousreports)(caseseries);(stimulatedreporting);(activesurveil2lance),(sentinelsites)(drugeventmonitoring)(registries);(comparativeobservationalstudies);(targetedclinicalinvestigations);(descriptivestudies),(naturalhistoryofdisease)(drugutilizationstudy)2(EuropeanMedicinesAgency,EMEA),,,(marketingauthourisationapplicants,MAAs)(marketingau2thourisationholders,MAHs),211(EURiskManagementPlan,EU2RMP)[2]EU2RMP2:1;2,(,)212EU2RMPEU2RMP,EU2RMP:,(ageneric/hybridmedici2nalproduct),()(),MAA/MAH,,,EU2RMP,:(hybridmedicinalproduct)213(safetyspecification)21311,(/)(QT871ChinJClinPharmacolVol125No12Mar12009(SerialNo1118))21312,:(limitationsofthehumansafetydata2base),,(--);,,(),(populationsnotstudiedinthepre2authorisationphase),():,;,-,/;,,,(backgroundincidencerates)(pharmacologcalclasseffects),,,,,214,,,;;;;215,MAA/MAH,,;,,,MAA/MAH(),,,EU2RMP,216(riskminimisationplan),,217(riskminimisationactivities),,,MAA/MAH,,(riskcommunication),,218(marketingauthorisation),219EU2RMP,EU2RMP:;60();3,SFDA(),,(183)971ChinJClinPharmacolVol125No12Mar12009(SerialNo1118);,,13,,;,,4,,,,,,,,,3,,[8],,:[1],1[J]1,2007;4:26522671[2],,,1[J]1,2003;12:28622891[3],,1[J]1,2004;20:12521261[4]1[J]1,2002;12:4291[5],,1FDA[J]1,2003;16:30523071[6]()1()[J]1,2004;1:592601[7]1[J]1,2006;21:1357213601[8]1[J]1,2005;5:35323561(179),2007,,,,,,:[1]ICH1E2Epharmacovigilanceplanning[EB/OL]1[2]EMEA1Guidelineonriskmnagementsystemsformedicinalproductsforhumanuse[EB/OL]1