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1、Tentativetranslation(asofOctober7,2008)Tentativetranslation(asofOctober7,2008)September1,2008OfficeofComplianceandStandardsPharmaceuticalsandMedicalDevicesAgencyGMPComplianceInspectionconcerningPharmaceuticals(includingAPIs)ofForeignManufacturers(Overvie
2、wGuidanceforForeignManufacturers)GMPComplianceInspectionconcerningPharmaceuticalsofForeignManufacturersisainspectiononthecomplianceofmanufacturingcontrolandqualitycontrolmethodsattherelevantmanufacturingsiteswithJapaneseGMP(“MinisterialOrdinanceonStandar
3、dsforManufacturingControlandQualityControlforDrugsandQuasi-drugs”,OrdinanceofMinistryofHealth,LabourandWelfare,No.179,2004),conductedbythePharmaceuticalsandMedicalDevicesAgency(hereinafter“PMDA”).GMPcomplianceisarequirementformarketingapproval.GMPComplia
4、nceInspectionsinclude1)Inspectionsthatareconductedatthepointofapplicationfornewmarketingapprovalorofapplicationforpartialchangesofapprovedinformation,and2)Inspectionsthatareconductedeveryfiveyearsfollowingtheobtainmentofmarketingapproval.Inthecaseofethic
5、aldrugs,packaging,labelingandstoragefacilitiesandexternaltestinglaboratoriesareincludedinthescopeofGMPInspection,inadditiontothemanufacturingsitesofdrugproducts,APIs(ActivePharmaceuticalIngredients)andintermediates.Inthecaseofapplicationforpartialchangea
6、pproval,GMPComplianceInspectionisnotrequiredifthepartialchangeisaddition,change,ordeletionetc.ofadministrationanddosage,orindicationthatwillnotaffectthemethodsformanufacturingcontrolorqualitycontrol.Whiledrugproductsforover-the-counterdrugsareincludedint
7、hescopeofGMPcomplianceInspection,APIsforover-the-counterdrugsareexcludedfromtheinspection(howeverAPIsofover-the-counterfornewmarketingapprovalareinthescopeofGMPcomplianceInspection).Amarketingauthorizationholderthatappliesforthemarketingapprovalofpharmac
8、eutical,oranappointedmarketingauthorizationholderdesignatedbyamanufacturerthatseekstoobtainforeignrestrictiveapproval,shallfileanapplicationwiththePMDAforGMPcomplianceInspectionofforeignmanufacturingsites.Followingtheappli
