韩国药品注册指南

ExplanatoryNotesforIndustryon”GuidelinetoRegistrationofDrugSubstances”March2004KoreaFoodandDrugAdministrationTableofContentsI.EXPLANATORYNOTESON“GUIDELINETOREGISTRATIONOFDRUGSUBSTANCES”(KFDANOTIFICATIONNO.2004-20,MARCH25,2004)1ARTICLE11ARTICLE26ARTICLE37ARTICLE41133ARTICLE51ARTICLE63SUPPLEMENTARYPROVISIONS33II.FAQ53III.“GUIDELINETOREGISTRATIONOFDRUGSUBSTANCES”(KFDANOTIFICATION2004-20,MARCH25,2004)34IV.REFERENCES80PIC/SSITEMASTERFILE80I.ExplanatoryNoteson“GuidelinetoRegistrationofDrugSubstances”(KFDANotificationNo.2004-20,March25,2004)Article1Article1(Purpose)Theaimofthisguidelineistoguideandfacilitatetheprocessofregistrationofdrugsubstancesbyprovidingmattersrelatedtothescopeofdrugsubstancestoregister,asdesignatedbytheCommissionerofKoreanFood&DrugAdministration(hereinafterreferredtoasKFDA),howtopreparethedata,thescopeofthedata,therequirementsofthedatatobesubmitted,theextentofexemptionfromsubmission,thestandardsforprocessingtheapplication,etc.pursuanttotheprovisionsofArticles26and34ofPharmaceuticalAffairsAct(hereinafterreferredtoastheAct)andalsoSubsection1,Paragraph1ofArticle23,Subsections6,Paragraph1andParagraph3ofArticle24,Paragraph1ofArticle40,andArticle83oftheEnforcementRuleundertheAct(hereinaftercalledtheEnforcementRule).NotesThisArticleistoprovidereferencepharmaceuticalaffairsregulations.!!“thescopeofdrugsubstancestoregister,asdesignatedbytheKFDA”isdefinedinArticle2.RelevantRegulationsPharmaceuticalAffairsAct!Article26(Licensingetc.ofmanufacturing)①AnyonewhointendstomanufacturedrugsormedicaldevicesshallgetalicensefromtheCommissioneroftheKoreaFoodandDrugAdministrationforeachproductandanyonewhointendstomanufacturesanitaryproductsshallnotifytheCommissioneroftheKFDAandeachproductshallbeapprovedornotified.IfthemanufacturerintendstochangetheapprovedornotifiedlabelasdesignatedbytheMinistryofHealthandWelfare,theapplicationofthechangeshallbesubmittedinaccordancewithanMarch20041ordinanceoftheMinistryofHealthandWelfare.AmendedonJanuary12,2000②AnyonewhointendstogetanapprovalfromornotifytheCommissionerundertheprovisionofParagraph①,shallestablishthenecessaryfacilitiesinaccordancewiththestandardsoffacilitiesasprovidedbythePresidentialDecree.AmendedonDecember31,1991③DeletedJanuary12,2000④～⑥(Omitted)Article34(Licensingetc.ofdrugimport)[EntirelyamendedinDecember31,1991]①Anyonewhointendstoimportdrugs(hereinafterreferredtoasimporter)shallgetalicensefromandnotifytheCommissioneroftheKFDAforeachproductinaccordancewithanordinanceoftheMinistryofHealthandWelfare.Sameprocedureshallbefollowedwhentheimporterintendstochangetheapprovedornotifiedlabel.AmendedonDecember13,1997andFebruary28,1998②Incaseanyoneintendstourgentlyimportdrugsnotmanufacturedinthecountryformilitaryaffairsinspiteoftheprovisionofthearticle①,theMinisteroftheNationalDefensecanimportthembydiscussingitemsandquantitywiththeCommissioneroftheKFDAinadvance.NewlyestablishedonDecember31,1994,December13,1997andFebruary28,1998③ImportershallestablishthenecessaryfacilitiesinaccordancewiththestandardsoffacilitiesasprovidedbythePresidentialDecree.AmendedonJanuary12,2000④ProvisionsofParagraph②,③,⑥-⑧ofArticle26,Article29-31andArticle68shallapplythiswithrespecttodrugsimportedinaccordancewiththeprovisionsofArticle1ortheirimporters.Inthiscase,manufacturingorproductionisregardedasimportandmanufacturerasimporter.AmendedonJanuary12,2000⑤IntheapprovalofimporteditemsincludingdrugsaccordingtotheprovisionsofArticle1,necessarydetailswithrespecttothesubject,standard,conditionandmanagementoftheapprovalaredecidedinaccordancewithanordinanceoftheMinistryofHealthandWelfare.NewlyestablishedonJanuary7,1994andDecember13,1997EnforcementRuleofPharmaceuticalAffairsAct!Article23(Licensingapplicationofmanufacturedandimporteditems)①AnyonewhointendstogetaitemlicensefordrugsinaccordancewithParagraph1ofArticle26orParagraph1ofMarch20042Article34ofPAAshallsubmitapplicationformaccordingtoNo.12formofannextogetherwithdocumentsbytheclassificationofthefollowingeachitemtotheCommissioneroftheKFDA.AmendedonMarch3,2000,June16,2000,January12,2002andNovember5,20021.DrugsㆍSanitaryproductsA.Lessthan2yearsofnotificationofsafetyandefficacyreviewapprovalinaccordancewiththeprovisionofArticle27ordatarequiredforthesafetyandefficacyreview.However,theyarenotsubmittedforitemsthatcomeunderoneofthefollowings:(1)ItemssuitableforstandardmanufacturingcriterianotifiedbytheCommissioneroftheKFDAwhostandardizesthetypes,normsandcontentsofcomponentsandprescription(2)ItemslistedinKoreaPharmacopoeia(KP)(3)ItemswhicharelistedinantibioticmonographundertheprovisionsofArticle44ofPAAoritemsnotlistedinKPwhicharelistedinHerbmonograph[hereinafterreferredtoas“Herbmonograph”](4)DNArecombinantdrugs,cellcultureproducts,biologicalproducts,celltherapyproducts,genetherapyproductsandsimilaritemswithsamefinalbulkasthatofitemsalreadylocallyapproved(5)ItemslistedinpharmacopoeiarecognizedbytheCommissioneroftheKFDAordrugformulary(6)ItemswhosespecificationsandtestmethodsareseparatelynotifiedbytheCommissioneroftheKFDA(7)Besides,itemsthattheCommiss