欧盟新版-药物警戒实践指南-解读-谢雁鸣

《》12*1.1007002.100700。。《》guidelineongoodpharmacovigilancepracticesGVP。《》GVP、、、、、、、。GVP、、。2013-04-28“”2009ZX09502-030*[e-mail][e-mail]-“”。、、1。。、2。。。20127。Euro-peanmedicinesagencyEMA《》guidelineongoodpharmacovigilancepracticesGVP“GVP”2《》therulesgoverningmedicinalproductsintheEuropeanUnion20079A《》guidelinesonpharmacovigilanceformedicinalprod-uctsforhumanuse“《》”3。GVP、。1GVP、EMA。EMA。EC726/20042001/83/EC22010EU1235/20102010/84/EUEC726/20042001/83/ECEU520/2012。2010GVP。。2GVPGVP“”mod-ule。EMAGVP16。1015。161。·3692·381820139Vol.38Issue18September20131GVPTable1ThemodulelistofGVPguideline1IIIIIIIVVVIVIIVIIIIXXXIXII-XIIIIXVXVXVI、120134。ABC3。A、B、C、。3GVP511。3.1pharmacovigilancesystemsandtheirqualitysystems、EMA。GVP。、、。3.2pharmacovigilancesystemmasterfile。、。、、、。3.3pharmacovigilanceinspections、、。、、。。。3.4pharmacovigilanceaudits、。①②③。3.5riskmanagementsystems3。、riskmanagementplanＲMPＲMPＲMPＲMP“”ＲMP“”ＲMP“”ＲMP“”ＲMP“”ＲMP“”ＲMP“”。·4692·381820139Vol.38Issue18September20133.6managementandreportingofadversereactionstomedicinalproducts、、、、。-。。3.7periodicsafetyupdatereportsPSUＲsPSUＲs-。PSUＲs-PSUＲs。PSUＲs、。PSUＲsPSUＲs-PSUＲsPSUＲsPSUＲsPSUＲs。3.8post-authorisationsafetystudiesPASSPASS。。PASSPASS-/。3.9signalmanagementEudraVigilanceEudraVigilanceEudraVigilance。。、。3.10additionalmonitoring。。。。3.11safetycommunication、EMA。、、。。。4GVP4.1、、、、、、、。。4.2、、、、、。、、、。、。4.3。4.3.1/、、、、、、、、·5692·381820139Vol.38Issue18September2013、、、、、。4.3.2、、、、。V。XVI。。4.3.3、、、、、。4.4、、、。、、、、。4.5PSUＲsPSUＲs。PSUＲs、、、、、、、、PSUＲs、、、、PSUＲs、、-。4.6①。、、。②、。、、-。③。。4.6.1-、、。4.6.2largesimpletrials。-。“”。4.6.3drugutilizationstud-iesDUS、、。、、、。。DUS。。4.7、、、、、。、、。、、、、Web、、、、。5《》《》GVP、、、、、、、。·6692·381820139Vol.38Issue18September20135.1EMA《》、、4GVP、EMAEMAEMA。5.2《》、、GVP、、、、、。。5.3PSUＲsGVP、-。5.4GVP、DUS、、、。5.5GVPＲMP。。/。、/、、、、QT。6GVP、EMA。PSUＲs-。EMAGVPEMAEMA。-。7GVP7.1、、、、。、、、、。7.2GVP、、。3①、、、、。②。、、、。③。、、、、、。、·7692·381820139Vol.38Issue18September2013、。、。1.J.200098513.2EuropeanMedicinesAgency.Guidelinesongoodpharmacovigi-lancepracticesEB/OL.2012-06-25.http//=pages/regulation/document_listing/document_listing_000345.jsp.3EuropeanCommission.Volume9AoftherulesgoverningmedicinalproductsintheEuropeanunionguidelinesonpharmacovigilanceformedicinalproductsforhumanuseEB/OL.2007-10-01．http//ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf.InterpretationofGuidelinesonGoodPharmacovigilancePracticesforEuropeanUnionXIEYan-ming1TIANFeng2*1.InstituteofBasicＲesearchinClinicalMedicineChinaAcademyofChineseMedicalSciencesBeijing100700China2.Post-DoctoralStationofChinaAcademyofChineseMedicalSciencesBeijing100700ChinaAbstractDuetothelimitationsofpre-authorizationclinicaltrialsthesafetyinformationobtainedfromthemisrelativelylim-ited．Thereforeitisverynecessarytocarryoutpharmacovigilanceactivitiesondrugspost-marketing．InordertopromotethespecificimplementationofthenewpharmacovigilanceregulationstheEuropeanmedicinesagencyEMAdevelopedtheGuidelineonGoodPharmacovigilancePracticesGVPasthenewcriteriaforpharmacovigilanceintheEuropeanUnionEU．Comparedwiththepre-viouslypublishedGuidelinesonPharmacovigilanceforMedicinalProductsforHumanUse2007theGVPproposedmorecompre-hensiveandsystematicprovisionsofpharmacovigilancesystemsqualitycontrolsystemsjudgementspharmacovigilanceinspectionsandaudits．Inadditionitsetmorespecificandcomprehensiverequirementsonriskmanagementsystemsthemanagementandrepor-tingofadversereactionstomedicinalproductsperiodicsafetyupdatereportspost-authorizationsafetystudiessignalmanagementandsoon．InterpretingthebasicprinciplesworkingmechanismskeytechnologiesandmethodsoftheGVPprovidesausefulreferenceforustocarryoutpharmacovigilanceespeciallyregardingsafetymonitoringofparenterallyadministeredChinesemedicine．KeywordsEuropeanUnionpharmacovigilanceguidelinesdoi10．4268/cjcmm20131809·8692·381820139Vol.38Issue18September2013