药品不良反应报告和监测管理办法英文版.docx
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药品不良反应报告和监测管理办法英文版.docx
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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
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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;
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(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.
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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.
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Article14Personnelengagedinadversedrugreactionreportingandmonitoringshallhavemedical,pharmaceutical,epidemiological,statisticalorotherrelevantbackground,andbecapableofmakingscientificanalysisandevaluationofadversedrugreaction.
ChapterIIIReportingandProcess
SectionIBasicRequirements
Article15Drugmanufacturers,drugdistributorsandmedicalinstitutionsshall,whenbecomesawareofanysuspectedadversedrugreaction,reportthroughtheadversedrugreactionmonitoringinformationnetwork.Ifonlinereportingisnotavailable,hardcopyreportshallbesubmittedtothelocaladversedrugreactionmonitoringbodyinstead,andthelocaladversedrugreactionmonitoringbodyshallmakeonlinereportingaccordingly.
Thereportedinformationshallbetrue,completeandaccurate.
Article16Adverse
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- 药品 不良反应 报告 监测 管理办法 英文