化学药品新注册分类申报资料要求 英文版51类.docx

化学药品新注册分类申报资料要求 英文版51类.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

ApplicationInformationRequirementsofChemicalDrugsaspernewregistrationcategory

ChapterI

ApplicationInformationRequirementsforCategory1,2,3,5.1

I.Requireditems

（I）Summary

1.Nameofthedrug

2.CertifiedDocuments

2.1Certifieddocumentsforcategory1,2,3

2.2Certifieddocumentsforcategory5.1

3.ObjectivesandbasisforR&D

4.Self-AssessmentReport

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

（III）Pharmaceuticalstudiesdata/documents

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:

character（suchasappearance,color,physicalstate）;meltingpointorboilingpoint;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