国家食品药品监督管理局药品特别审批程序英文版

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

2、r18,2005,isherebypromulgatedandshallgointoeffectasofthedateofpromulgation.                                                                                              ShaoMingli                                                                                              Co

3、mmissionerofSFDA                                                                                              November18,2005        SpecialReviewandApprovalProcedureforDrugRegistrationoftheStateFood and                                                           DrugAdminist

4、ration                                                   Chapter1   GeneralProvisionsArticle1   ThisProcedureisformulatedforthepurposeofeffectiveprevention,timelycontrolandeliminationofthehazardsofpublichealthemergenciestoensurethehealthandsafetyofthepublicinaccordancewitht

5、heDrugAdministrationLawofthePeople’sRepublicofChina,LawofthePeople’sRepublicofChinaonthePreventionandTreatmentofInfectiousDiseases,RegulationsforImplementationoftheDrugAdministrationLawofthePeople’sRepublicofChina,RegulationsonPreparednessforandResponsetoEmergentPublicHealt

6、hHazards,andotherrelevantlawsandregulations.Article2   ThespecialreviewandapprovalprocedurefordrugregistrationreferstotheprocedureandrequirementsoftheStateFoodandDrugAdministrationtocarryoutspecialreviewandapprovalofdrugsforhandlingpublicheathemergenciesundertheprincipleofu

7、nifiedleadership,earlyinvolvement,expeditiousnessandefficiency,andscientificreviewandapproval,inanefforttoapprovedrugsforthepreventionandtreatmentofpublichealthemergenciesassoonaspossibleunderthethreatoraftertheoccurrenceofpublicheathemergencies.Article3   TheStateFoodandDr

8、ugAdministrationmay,accordingtolaw,decidetofollowtheProceduretoconductspecialrevie