sfda-特殊审批管理办法英文版

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1、SpecialReviewandApprovalProcedureforDrugRegistrationoftheStateFoodandDrugAdministration(SFDADecreeNo.21)TheSpecialReviewandApprovalProcedureforDrugRegistrationoftheStateFoodandDrugAdministration,adoptedattheexecutivemeetingoftheStateFoodandDrugAdministration(SFDA)onNovember18,2005,isherebypromulgat

2、edandshallgointoeffectasofthedateofpromulgation.ShaoMingliCommissionerofSFDANovember18,2005SpecialReviewandApprovalProcedureforDrugRegistrationoftheStateFoodandDrugAdministrationChapter1GeneralProvisionsArticle1ThisProcedureisformulatedforthepurposeofeffectiveprevention,timelycontrolandeliminationo

3、fthehazardsofpublichealthemergenciestoensurethehealthandsafetyofthepublicinaccordaneewiththeDrugAdministrationLawofthePeople'sRepublicofChina,LawofthePeople'sRepublicofChinaonthePreventionandTreatmentofInfectiousDiseases,RegulationsforImplementationoftheDrugAdministrationLawofthePeople'sRepublicofC

4、hina,RegulationsonPreparednessforandResponsetoEmergentPublicHealthHazards,andotherrelevantlawsandregulations.Article2ThespecialreviewandapprovalprocedurefordrugregistrationreferstotheprocedureandrequirementsoftheStateFoodandDrugAdministrationtocarryoutspecialreviewandapprovalofdrugsforhandlingpubli

5、cheathemergenciesundertheprincipleofunifiedleadership,earlyinvolvement,expeditiousnessandefficiency,andscientificreviewandapproval,inanefforttoapprovedrugsforthepreventionandtreatmentofpublichealthemergenciesassoonaspossibleunderthethreatoraftertheoccurrenceofpublicheathemergencies・Article3TheState

6、FoodandDrugAdministrationmay,accordingtolaw,decidetofollowtheProceduretoconductspecialreviewandapprovalofdrugsforpublichealthemergenciesinanyofthefollowingcircumstances:(1)WherethePresidentofthePeople'sRepublicofChinadeclaresastateofemergencyortheStateCouncildecidesthatcertainareaswithinaprovince,a

7、utonomousregionormunicipalitydirectlyundertheCentralGovernmentareinastateofemergency;(2)Wherethecontingencyprogramforpublichealthemergenciesisinitiatedaccordingtolaw;(3)Wherethedrugreservedepartmentorthehea