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1、江苏省药品不良反应监测工作暂行规定（ProvisionalRegulationsonthemonitoringofadversedrugreactionsinJiangsu）ProvisionalRegulationsonthemonitoringofadversedrugreactionsinJiangsuChapterIGeneralProvisionsArticle1fortheadversedrugreactionnorms(hereinafterreferredtoasADR)monitoringwor
2、k,strengthensupervisionandmanagement,accordingtothe"People'sRepublicofChinaDrugAdministrationLaw"and"ADRreportingandmonitoringmanagementmeasures",theenactmentofthisprovision.Secondlevelsoffoodanddrugsupervisionandadministrationdepartmentresponsibleforthemonit
3、oringofADRintheadministrativeareas,thepharmaceuticalproductionenterprises,pharmaceuticaltradingenterprisesandmedicalinstitutionsandotherunits(hereinafterreferredtoastheADRmonitoringreportmonitoringreportunits)forthesupervisionandmanagementoftheworkcarriedout;
4、thehealthadministrativedepartmentsatalllevelsresponsibleforthemanagementofthemedicalandhealthinstitutionsandtheimplementationofADRreportingsystem.Thesecondchapter,organizationandpersonnelThirdmonitoringreportingunitsshouldsetupADRmonitoringinstitutionsordesig
5、natedspecialpersonnelresponsibleforADRmonitoringwork.FourthADRmonitoringstaffshouldhavethemedicalorpharmaceuticalandrelatedprofessionalknowledge,withtheabilitytoanalyzeandjudgeADRreports.Personnelshouldberegularlytrainedandassessed.Fifthmonitoringandreporting
6、unitsshouldformulateADRrelatedknowledgepublicityandtrainingprogram,inthisunittocarryoutpublicityandtrainingactivities.Thethirdchapter:facilitiesandequipmentThesixthmonitoringandreportingunitsshallhavecorrespondingsitesforADRmonitoring,andprovidebasicequipment
7、forwork,suchasInternetaccesscomputers,telephones,faxmachines,printers,etc..FacilitiesforpropermonitoringofADRrelatedinformationshouldbeproperlymaintained.ThefourthchapterismonitoringmanagementSeventhmonitoringreportingunitsshouldbeincludedintheADRmonitoringun
8、itannualtargetmanagementassessment,andtheunitADRmonitoringworkcarriedoutevaluationandsummary,atleastonceayear.EighthmonitoringandreportingunitsshouldformulateADRmonitoringworkrelatedtothe
