药品特别审批程序_英文版

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1、SpecialReviewandApprovalProcedureforDrugRegistrationoftheStateFoodandDrugAdministrationChapter1GeneralProvisionsArticle1ThisProcedureisformulatedforthepurposeofeffectiveprevention,timelycontrolandeliminationofthehazardsofpublichealthemergenciestoensurethehe

2、althandsafetyofthepublicinaccordancewiththeDrugAdministrationLawofthePeople’sRepublicofChina,LawofthePeople’sRepublicofChinaonthePreventionandTreatmentofInfectiousDiseases,RegulationsforImplementationoftheDrugAdministrationLawofthePeople’sRepublicofChina,Re

3、gulationsonPreparednessforandResponsetoEmergentPublicHealthHazards,andotherrelevantlawsandregulations.Article2ThespecialreviewandapprovalprocedurefordrugregistrationreferstotheprocedureandrequirementsoftheStateFoodandDrugAdministrationtocarryoutspecialrevie

4、wandapprovalofdrugsforhandlingpublicheathemergenciesundertheprincipleofunifiedleadership,earlyinvolvement,expeditiousnessandefficiency,andscientificreviewandapproval,inanefforttoapprovedrugsforthepreventionandtreatmentofpublichealthemergenciesassoonaspossib

5、leunderthethreatoraftertheoccurrenceofpublicheathemergencies.Article3TheStateFoodandDrugAdministrationmay,accordingtolaw,decidetofollowtheProceduretoconductspecialreviewandapprovalofdrugsforpublichealthemergenciesinanyofthefollowingcircumstances:(1)Wherethe

6、PresidentofthePeople’sRepublicofChinadeclaresastateofemergencyortheStateCouncildecidesthatcertainareaswithinaprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentareinastateofemergency;(2)Wherethecontingencyprogramforpublichealthemergenci

7、esisinitiatedaccordingtolaw;(3)WherethedrugreservedepartmentorthehealthadministrativedepartmentoftheStateCouncilproposesaspecialreviewandapprovalfordrugshavingexistingnationaldrugstandard;(4)Othercircumstancesapplicabletospecialreviewandapproval.Article4The

8、StateFoodandDrugAdministrationisresponsibleforthereviewandapprovalofclinicaltrials,productionandimportationofdrugsforthepreventionandtreatmentofpublichealthemergencies.The(foodand)drugregulatorydepartm