药品特别审批程序_英文版

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1、SpecialReviewandApprovalProcedureforDrugRegistrationoftheStateFoodandDrugAdministrationChapter1GeneralProvisionsArticle1ThisProcedureisformulatedforthepurposeofeffectiveprevention,timelycontrolandeliminationofthehazardsofpublichealthemergenciestoensur

2、ethehealthandsafetyofthepublicinaccordancewiththeDrugAdministrationLawofthePeople’sRepublicofChina,LawofthePeople’sRepublicofChinaonthePreventionandTreatmentofInfectiousDiseases,RegulationsforImplementationoftheDrugAdministrationLawofthePeople’sRepubl

3、icofChina,RegulationsonPreparednessforandResponsetoEmergentPublicHealthHazards,andotherrelevantlawsandregulations.Article2ThespecialreviewandapprovalprocedurefordrugregistrationreferstotheprocedureandrequirementsoftheStateFoodandDrugAdministrationtoca

4、rryoutspecialreviewandapprovalofdrugsforhandlingpublicheathemergenciesundertheprincipleofunifiedleadership,earlyinvolvement,expeditiousnessandefficiency,andscientificreviewandapproval,inanefforttoapprovedrugsforthepreventionandtreatmentofpublichealthe

5、mergenciesassoonaspossibleunderthethreatoraftertheoccurrenceofpublicheathemergencies.Article3TheStateFoodandDrugAdministrationmay,accordingtolaw,decidetofollowtheProceduretoconductspecialreviewandapprovalofdrugsforpublichealthemergenciesinanyofthefoll

6、owingcircumstances:(1)WherethePresidentofthePeople’sRepublicofChinadeclaresastateofemergencyortheStateCouncildecidesthatcertainareaswithinaprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentareinastateofemergency;(2)Wherethecontin

7、gencyprogramforpublichealthemergenciesisinitiatedaccordingtolaw;(3)WherethedrugreservedepartmentorthehealthadministrativedepartmentoftheStateCouncilproposesaspecialreviewandapprovalfordrugshavingexistingnationaldrugstandard;(4)Othercircumstancesapplic

8、abletospecialreviewandapproval.Article4TheStateFoodandDrugAdministrationisresponsibleforthereviewandapprovalofclinicaltrials,productionandimportationofdrugsforthepreventionandtreatmentofpublichealthemergencies.The(foodand)drugregulatorydepartm