《国家食品药品监督管理局药品特别审批程序》(21号令)英文版

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

2、,isherebypromulgatedandshallgointoeffectasofthedateofpromulgation.                                                                                              ShaoMingli                                                                                              CommissionerofSFDA

3、                                                                                              November18,2005        SpecialReviewandApprovalProcedureforDrugRegistrationoftheStateFood and                                                           DrugAdministration                  

4、                                 Chapter1   GeneralProvisionsArticle1   ThisProcedureisformulatedforthepurposeofeffectiveprevention,timelycontrolandeliminationofthehazardsofpublichealthemergenciestoensurethehealthandsafetyofthepublicinaccordancewiththeDrugAdministrationLawofthePeop

5、le’sRepublicofChina,LawofthePeople’sRepublicofChinaonthePreventionandTreatmentofInfectiousDiseases,RegulationsforImplementationoftheDrugAdministrationLawofthePeople’sRepublicofChina,RegulationsonPreparednessforandResponsetoEmergentPublicHealthHazards,andotherrelevantlawsandregulati

6、ons.Article2   ThespecialreviewandapprovalprocedurefordrugregistrationreferstotheprocedureandrequirementsoftheStateFoodandDrugAdministrationtocarryoutspecialreviewandapprovalofdrugsforhandlingpublicheathemergenciesundertheprincipleofunifiedleadership,earlyinvolvement,expeditiousnes

7、sandefficiency,andscientificreviewandapproval,inanefforttoapprovedrugsforthepreventionandtreatmentofpublichealthemergenciesassoonaspossibleunderthethreatoraftertheoccurrenceofpublicheathemergencies.Article3   TheStateFoodandDrugAdministrationmay,accordingtolaw,decidetofollowtheProc

8、eduretoconductspecialrevie