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中国化药注册分类（旧分类、新分类）ClassificationofRegistrationofChemicalDrugsinChina(TheOldClassificationandtheNewClassification)旧的注册分类是来源于2007年10月1日实施的《药品注册管理办法》（局令第28号）的附件2《化学药品注册分类及申报资料要求》（此注册分类实际在28号令之前就实施的，早期历史文件不再追溯）。TheoldclassificationofregistrationdatedfromtheAnnex2“RegisteredClassificationofChemicalsandRequirementsofApplication”of“AdministrativeProvisionofDrugRegistration”(BoardOrderNo.28),whichimplementedonOctober1st,2007(Actually,thiscategoryhadbeenimplementedearlierthanthedateoftheimplementationofthe28orders,andtheearlyhistoryfileisnolongertraceable).旧的药品注册分类如下：/Theoldclassificationofregistrationofdrugisasfollows:注册分类/classification分类说明/Description包含的情形/includedconditions1未在国内外上市销售的药品/drugsthatarenotmarketedbothdomesticallyandabroad1.1通过合成或者半合成的方法制得的原料药及其制剂/thedrugs(APIanditspreparation)obtainedbysyntheticorsemisyntheticmethod.1.2天然物质中提取或者通过发酵提取的新的有效单体及其制剂/theneweffectivemonomeranditspreparationsareextractedfromnatural-occurringsubstanceorextractedbyfermentation.1.3用拆分或者合成等方法制得的已知药物中的光学异构体及其制剂/thedrugs(opticalisomeranditspreparation)obtainedbysplitorsyntheticmethods,ect.1.4由已上市销售的多组份药物制备为较少组份的药物/thedrugscontainslesscomponentsareobtainedfromdrugscontainsmulticomponentsthathavebeenmarketed1.5新的复方制剂/newcompoundpreparation1.6已在国内上市销售的制剂增加国内外均未批准的新适应症/thepreparationsthathavebeenmarketedbothdomesticallyandabroadwithnewindicationswhicharenotapprovedaboardanddomestically.2改变给药途径且尚未在国内外上市销售的制剂/modifiednewpreparations(changerouteofadministration)thatarenotmarketedbothdomesticallyandabroad3已在国外上市销售但尚未在国内上市销售的药品/thedrugsthathavebeenmarkedabroadbutnotdomestically3.1已在国外上市销售的制剂及其原料药，和/或改变该制剂的剂型，但不改变给药途径的制剂/thepreparationsanditsAPIthathavebeenmarketedaboardand/oritsdosageformischangedbutrouteofadministrationisnotchanged.3.2已在国外上市销售的复方制剂，和/或改变该制剂的剂型，但不改变给药途径的制剂/thecompoundpreparationsthathavebeenmarketedaboardand/oritsdosageformischangedbutrouteofadministrationisnotchanged.3.3改变给药途径并已在国外上市销售的制剂/thepreparationsthathavebeenmarketedaboardanditsrouteofadministrationischanged.3.4国内上市销售的制剂增加已在国外批准的新适应症/thepreparationsthathavebeenmarketeddomesticallywithnewindicationswhichareapprovedaboard4改变已上市销售盐类药物的酸根、碱基（或者金属元素），但不改变其药理作用的原料药及其制剂/changetheacidradical,base(ormetallicelement)ofsaltdrugsthathavebeenmarketed,butnotchangeitspharmacologicaleffects.5改变国内已上市销售药品的剂型，但不改变给药途径的制剂/changethedosageformofpreparationsthathavebeenmarketeddomestically,butnotchangeitsrouteofadministration6已有国家药品标准的原料药或者制剂/theAPIorpreparationthatNationalSpecificationhasbeenestablished.进口化学药品申报，申请未在国内外获准上市销售的药品，按照注册分类1的规定报送资料；其他品种按照注册分类3的规定报送资料。也可以报送ICH规定的CTD资料，但“综述资料”部分应按照化学药品《申报资料项目》要求报送。属于注册分类1的药物，应当至少是已在国外进入II期临床试验的药物。Fortheapplicationofimportchemicaldrugs,applythedrugswhicharenotapprovedformarketingindomestic,submitthedocumentationinaccordingtotheprovisionsofClassified1;othersdrugsshouldapplyinaccordingtotheprovisionsofClassified3.AlsosubmittheCTDdocumentationinaccordingtoICHispermitted,but,thepartof“DocumentationofReview”shouldbesubmittedinaccordingtotherequirementsof“ProjectsofApplicationdocumentation”.ThedrugsofClassified1shouldbeatleasthasenteredPhaseIIclinicaltrialsofthedruginaforeigncountry.2016年3月4日国家食品药品监督管理总局（CFDA）正式发布《关于发布化学药品注册分类改革工作方案的公告（2016年第51号）》，并自公告发布之日起实施。OnMarch4th,2016,theStateFoodandDrugAdministration(CFDA)wasofficiallyissued“Noticeofreformingaboutregisteredclassificationofchemicaldrugs”(No.51of2016),andimplementedfromtheissueddate.新的药品注册分类如下：/Thenewclassificationofregistrationofdrugisasfollows:注册分类/classification分类说明/Description包含的情形/includedconditions1境内外均未上市的创新药/innovativedrugsthatarenotmarketedbothdomesticallyandabroad含有新的结构明确的、具有药理作用的化合物，且具有临床价值的原料药及其制剂。/thesedrugs(APIanditspreparation)containnewcompoundswithclearstructuresandpharmacologicaleffectsandtheyhaveclinicalvalue2境内外均未上市的改良型新药/modifiednewdrugsthatarenotmarketedbothdomesticallyandabroad2.1含有用拆分或者合成等方法制得的已知活性成份的光学异构体，或者对已知活性成份成酯，或者对已知活性成份成盐（包括含有氢键或配位键的盐），或者改变已知盐类活性成份的酸根、碱基或金属元素，或者形成其他非共价键衍生物（如络合物、螯合物或包合物），且具有明显临床优势的原料药及其制剂。/thedrugs(APIanditspreparation)obtainedbysplitorsyntheticmethods,etc.andcontainsopticalisomerwithknownactiveingredients,orformingasterfromknownactiveingredients,orformingsaltfromknownactiveingredients(includingsaltcontainhydrogenbondorcoordinationbond),orchangetheacidradical,baseormetallicelementofknownactiveingredients,orformingothernon-covalentderivatives(suchascomplexes,chelates,orinclusioncomplexes)andhassignificantclinicalvalue.2.2含有已知活性成份的新剂型（包括新的给药系统）、新处方工艺、新给药途径，且具有明显临床优势的制剂。/thesedrugs(APIanditspreparation)containnewdosageformswithknownactiveingredients(includingnewadministrationsystem),newformulationprocess,newrouteofadministrationandthepreparationhassignificantclinicalvalue.2.3含有已知活性成份的新复方制剂，且具有明显临床优势。/thenewcompoundpreparationcontainsknownactiveingredientsandhassignificantclinicalvalue.2.4含有已知活性成份的新适应症的制剂。/thepreparationcontainsnewindicationswithknownactiveingredients.3仿制境外上市但境内未上市原研药品的药品/thedrugsthatareimitatedbydomesticapplicantstooriginaldrugsthathavebeenmarkedabroadbutnotdomestically具有与原研药品相同的活性成份、剂型、规格、适应症、给药途径和用法用量的原料药及其制剂。/thiskindofdrugs(APIa