化学药品新注册分类申报资料要求 英文版51类Word文件下载.docx
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化学药品新注册分类申报资料要求 英文版51类Word文件下载.docx
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5.InformationofMarketingAuthorizationHolder
6.Informationoforiginaldrug
7.Draftofpackaginginsert,notetothedraft,andrelevantreferenceliterature
8.Specimenofthedesignedpackageandlabel
(II)SummaryofthemainStudies
9.Summaryofpharmaceuticalstudies
10.Summaryofnon-clinicalstudies
11.Summaryofclinicalstudies
(III)Pharmaceuticalstudiesdata/documents
12.(3.2.S)DrugSunstance(3.2.SistheNo.ofCTDformat)
12.1(3.2.S.1)Generalinformation
12.2(3.2.S.2)Manufacture
12.3(3.2.S.3)Characterisation
12.4(3.2.S.4)Controlofdrugsubstance
12.5(3.2.S.5)Referencestandardsormaterials
12.6(3.2.S.6)ContainerClosureSystem
12.7(3.2.S.7)Stability
13.(3.2.P)DrugProduct
13.1(3.2.P.1)Descriptionandcompositionofthedrugproduct
13.2(3.2.P.2)Pharmaceuticaldevelopment
13.3(3.2.P.3)Manufacture
13.4(3.2.P.4)Controlofdrugsubstanceandexcipients
13.5(3.2.P.5)ControlDrugProduct
13.6(3.2.P.6)Referencestandardsormaterials
13.7(3.2.P.7)Stability
(IV)Nonclinicalstudiesdata/documents
14.Summaryofnonclinicalstudies
15.Mainpharmacologytestsdocumentsandliteratures
16.Safetypharmacologytestsdocumentsandliteratures
17.Singe-dosetoxicitytestsdocumentsandliteratures
18.Repeat-dosetoxicitytestsdocumentsandliteratures
19.Genotoxicitytestsdocumentsandliteratures
20.Reproductivetoxicitytestsdocumentsandliteratures
21.Carcinogenicitytestsdocumentsandliteratures
22.Dependencetestsdocumentsandliteratures
23.Specialsafetytestsdocumentsandliteraturesincludingbutnotlimitedtohypersusceptibility(topic,pantasomatousandphotosenstitivetoxicity),hemocytolysisandtopicaltopicalirritation(bloodvessel,skin,mucousmemberbrance,muscleandetc.)
24.Othersafetytestsdocumentsandliteratures
25.Nonclinicalpharmacokineticstestsdocumentsandliteratures
26.Testsdocumentsandliteraturesonmutualeffectbetweenpharmacology,toxicityandpharmacokineticsofthemultipleingredientsincompounddrugproducts/formulation
(V)Clinicaltestsdocuments
27.Summaryofclinicaltestsdocuments
28.Clinicaltestsplanandstudyprotocol
29.Datamanagementplan,statisticalanalysis
30.Investigator’sbrochure
31.Draftofinformedconsentform,approvaloftheethicscommittee,reviewreportofsciencecommittee
32.Clinicaltestsreport
33.Electronicfileofclinicaltestsdata
34.Reportofdatamanagement,reportofstatisticalanalysis
12.(3.2.S)DrugSubstance
12.1(3.2.S.1)GeneralInformation
3.2.S.1.1Nameofthedrug
PleaseprovideChineseandEnglishgenericnames,chemicalnames,CASnumbersandothernamesofdrugsubstance(includingthoseinforeignpharmacopoeia).
3.2.S.1.2Structure
Pleaseprovidethestructuralformula,molecularformula,andmolecularweightofDrugsubstance.Iftherearethree-dimensionalstructuresandpolymorphs,itshouldbespecified.
3.2.S.1.3Physicochemicalproperties
Pleaseprovidethephysicalandchemicalpropertiesofthedrugsubstance(generallyderivedfrompharmacopoeiaandMerckindex,etc.),includingthefollowinginformation:
character(suchasappearance,color,physicalstate);
meltingpointorboilingpoint;
specificrotation,solubility,solutionpH,Partitioncoefficient,dissociationconstant,physicalform(suchaspolymorph,solvate,orhydrate)thatwillbeusedforpreparationproduction,particlesize,etc..
12.2(3.2.S.2)Manufacture
3.2.S.2.1Manufacturer
Pleaseprovidethemanufacturer'
sname(fullname),address,telephonenumber,faxnumber,andtheaddressoftheproductionsite(specificallytotheplant/shop,productionline),telephone,fax,etc.
3.2.S.2.2Manufacturingprocessandcontrol
(1)Flowchart:
Aflowchartisprovidedaccordingtotheprocesssteps,indicatingtheprocessparametersandthesolventused.Forchemicallysynthesizeddrugsubstance,itshouldalsoprovideitschemicalreactionformula,whichshouldincludethestartingmaterials,intermediates,moleculeformula/moleculeweight/structureofthereagents.
(2)Descriptionofthemanufactureprocess:
Theprocessoperationisdescribedbytheprocessflow,representedbytheregisteredbatch.Theamountsofeachreactionmaterialandtheyieldrangeofeachsteparelisted,andthekeyproductionsteps,keyprocessparametersandqualitycontrolindicatorsoftheintermediatesareclarified.
(3)Equipments:
Pleaseprovidetheinformationofthemainandspecialequipments(suchastype,technicalparameters,commonbatchsizerange,manufacturer,thereactionstepsused).
(4)Indicatethebatchsizerangeofcommercialbatches.
Thedetaileddegreeofproductionprocessdescriptionshouldenablethetechniciansofthisspecialtytocompletelyrepeattheproductionprocessaccordingtothedeclaredproductionprocessandproduceproductsthatmeetthestandards.
3.2.S.2.3Controlofmaterials
Accordingtotheprocessintheprocessflowchart,allthematerialsusedintheproduction(suchasstartingmaterials,reagents,solvents,catalysts,etc.)arelistedintheformofatable,andthestepsusedareexplained.Anexampleisasfollows:
Table1(Note:
serialnumber,thesamebelow):
materialcontrolinformation
Nameofmaterial
Qualitystandard
Manufacturer
Stepsforusage
Pleaseprovidequalitycontrolinformationfortheabovematerials,specifyreferencestandards,orprovideinternalcontrolstandards(includingitems,testingmethodsandlimits),andprovidenecessarymethodologicalverificationdata.
Forthekeystartingmaterials,thepreparationprocessdatashouldbeprovidedaccordingtotherelevanttechnicalguidelinesandtechnicalrequirements.
3.2.S.2.4Controlofcriticalstep&
intermediate
Listallkeysteps(includingfinalproductrefiningandpurificationprocesssteps)andcontrolrangeofprocessparameters.
Listthequalitycontrolstandardsforisolatedintermediates,includingitems,methodsandlimits,andprovidenecessarymethodologicalverificationdata.
3.2.S.2.5Evaluationandvalidationofthemanufactureprocess
Processvalidationdata,includingprocessvalidationprotocolandvalidationreport,shouldbeprovidedforsteriledrugsubstance.Forotherdrugsubstance,onlyprocessvalidationprotocolsandbatchproductionrecordsamplescanbeprovided,butthecommitmenttovalidatethefirstthreebatchesofcommercialproductionbatchesafterapprovalshouldbesubmittedatthesametime.Validationprotocol,validationreport,batchproductionrecordshouldbenumbered,andshouldbesignedbyappropriatepersonnel(suchasQA,QC,qualityandproductionmanager,etc.).
3.2.S.2.6Manufacturingprocessdevelopment
Providetheselectionbasisofthemanufactureprocess(includingliteraturebasisandtheorybasis).
Detailedresearchdata(includingresearchmethods,researchresultsandresearchconclusions)areprovidedtoillustratetherationalityofkeystepsdeterminationandtherationalityofprocessparameterscontrolrange.
Themainchangesofproductionprocessintheprocessofprocessdevelopment(includingbatch,equipment,processparametersandprocessroutes)andrelatedsupportingvalidationresearchdataaredescribedindetail.
Asummarytableofprocessresearchdataisprovided.Anexampleisasfollows:
TableXX:
Asummarytableofprocessresearchdata
Batchnumber
Dateofmanufacture
Siteofmanufacture
Objectiveofmanufacture/sample1
Batch
Yield
Process2
Samplequality
Assay
Impurity
Character
Note:
1:
Describethepurposeofproducingthebatchandtheuseofthesample,suchasprocessvalidation/stabilitystudies;
2:
ExplainwhethertheproductionprocessofthebatcheslistedinthetableisconsistentwiththeprocessunderS.2.2.Iftheyareinconsistent,thedifferencesshouldbeclarified.
12.3(3.2.S.3.)Characterizations
3.2.S.3.1Structureandphysiochemicalproperties
(1)Confirmationofthestructure
Thestructureoftheproductisanalyzedbycombiningthesyntheticrouteandvariousstructuralconfirmationmethods.Ifitmaycontainthree-dimensionalstructure,crystallinewater/crystallinesolventorpolycrystallineform,itshouldbeexplainedindetail.
Providethemethodofpurification,purity,batchnumberofthesampleforstructuralconfirmation.Ifthereferencesubstanceisused,thesource,purityandbatchnumberofthereferencesubstanceshouldbeexplained;
specificresearchdataandspectraareprovidedandanalyzed.Forspecificrequirements,pleaserefertotheTechnicalGuidelinesforthePreparationandStructuralConfirmationofDrugsubstanceofChemicalDrugs.
(2)Physicochemicalproperties
Providedetailedphysicochemicalinformation,including:
specificrotation,solubility,hygroscopicity,solutionpH,partitioncoefficient,dissociationconstant,physicalmorphology(suchaspolycrystalline,solventsorhydrates)tobeusedinpreparationproduction,particlesize,etc
3.2.S.3.2Impurities
Listthepossibleimpurities(includingorganicimpurities,inorganicimpurities,residualsolventsandcatalysts)intheproduct,analyzethesourcesofimpurities(fromsyntheticrawmaterials,by-productsproducedintheproductionpro
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