药品不良反应报告和监测管理办法英文版.docx

药品不良反应报告和监测管理办法英文版.docx

《药品不良反应报告和监测管理办法英文版.docx》由会员分享，可在线阅读，更多相关《药品不良反应报告和监测管理办法英文版.docx（17页珍藏版）》请在冰豆网上搜索。

药品不良反应报告和监测管理办法英文版

药品不良反应报告和监测管理办法-英文版

ProvisionsforAdverseDrugReactionReportingandMonitoring（OrderNo.81

oftheMinistryofHealth）

Announcedon4May2011

OrderoftheMinistryofHealthofthePeople’sRepublicofChina

No.81

TheProvisionsforAdverseDrugReactionReportingandMonitoringapprovedinthe

conferenceonministerialaffairsheldbytheMinistryofHealthon13December2010

isherebyannouncedforimplementationasof1July2011.

ChenZhu,Minister

4May2011

1

ProvisionsforAdverseDrugReactionReportingandMonitoring

ChapterIGeneralProvisions

Article1TheseProvisionsareformulatedaccordingtotheDrugAdministration

LawofthePeople’sRepublicofChinaandotherrelevantlawsandregulationsforthe

tandardizeadversepurposeofstrengtheningsupervisionoverdrugsinthemarket,s

drugreactionreportingandmonitoring,andcontrollingdrugrisktimelyandeffectivelytoensurethesafetyofpublicdruguse.

Article2TheseProvisionsareapplicabletoactivitiesrelatedtoreporting,monitoringandsupervisionofadversedrugreactionwithintheterritoryofthePeople’sRepublicofChina.

Comments:

excludingHongKong,Taiwan,andMacao

Article3TheStateadoptstheadversedrugreactionreportingsystem.Drugmanufacturers（includingoverseasmanufacturersofimporteddrugs）,drugdistributorsandmedicalinstitutionsshallreportadversedrugreactionidentifiedbytheminaccordancewithrelevantprovisions.

Article4TheStateFoodandDrugAdministrationshallbeinchargeofimplementationofadversedrugreactionreportingandmonitoringacrossthenation.Localdrugregulatorydepartmentsshallbeinchargeofimplementationofadversedrugreactionreportingandmonitoringwithintheirrespectivejurisdiction.Healthadministrativedepartmentsatvariouslevelsshallberesponsiblefortheimplementationoftheadversedrugreactionreportingsystembymedicalinstitutionswithintheirrespectivejurisdiction.

Localhealthadministrativedepartmentsatvariouslevelsshallestablishandmaintainanadversedrugreactionmonitoringbodytobeinchargeofthetechnicalaspectofadversedrugreactionreportingandmonitoringwithintheirrespectivejurisdiction.Article5TheStateencouragesallcitizens,legalpersonsandotherorganizationstoreportadversedrugreaction.

ChapterIIResponsibilities

Article6TheStateFoodandDrugAdministrationshallbeinchargeofimplementationofadversedrugreactionreportingandmonitoringacrossthenationandshallperformthefollowingduties:

（A）To,byworkingwiththeMinistryofHealth,prepareregulationsandpoliciesforadversedrugreactionreportingandmonitoring,andtosuperviseimplementationthereof;

（B）To,byworkingwiththeMinistryofHealth,investigateandhandlegroupadversedrugreactioneventswhichhavecausedsevereconsequencesandhavegreatimpactnationwidely,andtoreleaserelevantinformation;

2

（C）Totakeemergencycontrolmeasuresoverdrugswhichhavecausedidentifiedseriousadversedrugreactionorclusteradversedrugevents,makeadministrativepunishmentdecisions,andmakeannouncementtothepublic;

（D）Toissuebulletinonadversedrugreactionreportingandmonitoringnationly;（E）Toinspectadversedrugreactionreportingandmonitoringactivitiescarriedoutbydrugmanufacturersanddrugdistributors,andto,byworkingwiththeMinistryofHealth,inpsectadversedrugreactionreportingandmonitoringactivitiescarriedoutbymedicalinstitutions.

Article7Drugregulatorydepartmentsofprovinces,autonomousregionsandmunicipalitiesshallbeinchargeofimplementationofadversedrugreactionreportingandmonitoringwithintheirrespectivejurisdictionandshallperformthefollowingduties:

（A）To,byworkingwiththehealthadministrativedepartmentatthesamelevel,prepareregulationsandpoliciesforadversedrugreactionreportingandmonitoringwithintheirrespectivejurisdiction,andtosuperviseimplementationthereof;（B）To,byworkingwiththehealthadministrativedepartmentatthesamelevel,investigateandhandleclusteradversedrugeventswhichhavecausedsevereconsequencesandhavegreatimpactwithintheirrespectivejurisdiction,andtoreleaserelevantinformation;

（C）Totakeemergencycontrolmeasuresoverdrugswhichhavecausedidentifiedsevereadversedrugreactionorclusteradversedrugevents,makeadministrativepunishmentdecisions,andmakeannouncementtothepublic;

（D）Toissuebulletinonadversedrugreactionreportingandmonitoringwithintheirrespectivejurisdiction;

（E）Toinspectadversedrugreactionreportingandmonitoringactivitiescarriedoutbydrugmanufacturersanddrugdistributorswithintheirrespectivejurisdiction,andto,byworkingwiththehealthadministrativedepartmentatthesamelevel,inspectadversedrugreactionreportingandmonitoringactivitiescarriedoutbymedicalinstitutionswithintheirrespectivejurisdiction;and

（F）Toorganizepropagandaandtrainingonadversedrugreactionreportingandmonitoringwithintheirrespectivejurisdiction.

Article8Drugregulatorydepartmentsatmunicipal/countylevelundertheircompetentprovincialdepartmentshallbeinchargeofimplementationofadversedrugreactionreportingandmonitoringwithintheirrespectivejurisdiction.Theyshall,byworkingwiththehealthadministrativedepartmentthesamelevel,investigateclusteradversedrugeventswithintheirrespectivejurisdictionandtakenecessarycontrolmeasures,andshallcarryoutpropagandaandtrainingonadversedrugreactionreportingandmonitoringwithintheirrespectivejurisdiction.Article9Healthadministrativedepartmentsabovecountylevelshallstrengthenregulatorymanagementofclinicaluseofdrugsbymedicalinstitutions,andshalltakeemergencycontrolmeasuresagainstidentifiedseriousadversedrugreactionorclusteradversedrugeventswithintheirscopeofpoweraccordingtolaw.

3

Article10TheNationalAdverseDrugReactionMonitoringCentershallbeinchargeofthetechnicalaspectofadversedrugreactionreportingandmonitoringandshallperformthefollowingduties:

（A）Tocollect,evaluate,feedbackandreportadversedrugreactionreportingandmonitoringdataacrossthenation,andtoconstructandmaintaintheNationalAdverseDrugReactionMonitoringInformationNetwork;

（B）Topreparethetechnicalstandardsandnormsforadversedrugreactionreportingandmonitoring,andtoprovidetechnicalguidancetolocaladversedrugreactionmonitoringbodies;

（C）Toorganizetheinvestigationandevaluationofseriousadversedrugreactions,andtoassistrelevantdepartmentstocarryoutinvestigationonclusteradversedrugevents;

（D）Toreleaseadversedrugreactionalerts;and

（E）Toorganizepropaganda,training,researchandinternationalexchangeregardingadversedrugreactionreportingandmonitoring.

Article11Adversedrugreactionmonitoringbodiesatprovinciallevelshallbeinchargeofthetechnicalaspectofadversedrugreactionreportingandmonitoringwithintheirrespectivejurisdictionandshallperformthefollowingduties:

（A）Tocollect,evaluate,feedbackandreportadversedrugreactionreportingandmonitoringdatawithintheirrespectivejurisdiction,andtomaintainandmanagetheadversedrugreactionmonitoringinformationnetwork;

（B）Toprovidetechnicalguidancetoadversedrugreactionmonitoringbodiesatmunicipal/countylevel（whichmunicipalityorcountyisdividedbydistricts）;（C）Toorganizetheinvestigationandevaluationofseriousadversedrugreactionswithintheirrespectivejurisdiction,andtoassistrelevantdepartmentstocarryoutinvestigationonclusteradversedrugevents;

（D）Toorganizepropagandaandtrainingonadversedrugreactionreportingandmonitoringwithintheirrespectivejurisdiction.

Article12adversedrugreactionmonitoringbodiesatmunicipal/countylevelundertheircompetentprovincialdepartmentshallcollect,verify,evaluate,feedbackandreportadversedrugreactionreportingandmonitoringdatawithintheirrespectivejurisdiction,organizetheinvestigationandevaluationofseriousadversedrugreactionswithintheirrespectivejurisdiction,assistrelevantdepartmentstocarryoutinvestigationongroupadversedrugreactionevents,andorganizepropagandaandtrainingonadversedrugreactionreportingandmonitoring.

Article13Drugmanufacturers,drugdistributorsandmedicalinstitutionsshallestablishanadversedrugreactionreportingandmonitoringsystem.Drugmanufacturersshallsetupanindependentunitanddesignatefull-timestafftobeinchargeoftheadversedrugreactionreportingandmonitoring.Drugdistributorsandmedicalinstitutionsshallsetupordesignatefull-timeorpart-timestaff（s）fromanindependentunittobeinchargeoftheadversedrugreactionreportingandmonitoringt.

4

Article14Personnelengagedinadversedrugreactionreportingandmonitoringshallhavemedical,pharmaceutical,epidemiological,statisticalorotherrelevantbackground,andbecapableofmakingscientificanalysisandevaluationofadversedrugreaction.

ChapterIIIReportingandProcess

SectionIBasicRequirements

Article15Drugmanufacturers,drugdistributorsandmedicalinstitutionsshall,whenbecomesawareofanysuspectedadversedrugreaction,reportthroughtheadversedrugreactionmonitoringinformationnetwork.Ifonlinereportingisnotavailable,hardcopyreportshallbesubmittedtothelocaladversedrugreactionmonitoringbodyinstead,andthelocaladversedrugreactionmonitoringbodyshallmakeonlinereportingaccordingly.

Thereportedinformationshallbetrue,completeandaccurate.

Article16Adverse