Annex 2.docx

Annex 2.docx

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Annex2

Annex2:

RegistrationCategoriesandApplicationInformationRequirementsofChemicalDrugs

I    RegistrationCategories

1）  Newchemicalentitynevermarketedinanycountry.

i.  Drugsubstanceanditspreparationsmadebysynthesisorsemi-synthesis.

ii.  Chemicalmonomer（includingdrugsubstanceandpreparation）extractedfromnaturalsourcesorbyfermentation.

iii.  Opticalisomer（includingdrugsubstanceandpreparation）obtainedbychiralseparationorsynthesis.

iv.  Drugwithfewercomponentsderivedfrommarketedmulti-componentdrug.

v.  Newcombinationproducts.

vi.  ApreparationalreadymarketedinChinabutwithanewlyaddedindicationnotyetapprovedinanycountry.

2）  Drugpreparationwithchangedadministrationrouteandnotmarketedinanycountry

3）  Drugmarketedex-China,including:

i.  Drugsubstanceanditspreparations,and/orwithchangeddoseform,butnochangeofadministrationroute.

ii.  Combinationpreparations,and/orwithchangeddoseform,butnochangeofadministrationroute.

iii.  Preparationswithchangedadministrationrouteandmarketedex-China.

iv.  ApreparationalreadymarketedinChinabutwithanewlyaddedindicationapprovedex-China.

4）  Drugsubstanceanditspreparationwithchangedacidoralkalineradicals（ormetallicelements）,butwithoutanypharmacologicalchange,andtheoriginaldrugentityalreadyapprovedinChina.

5）  Drugpreparationwithchangeddoseform,butnochangeofadministrationroute,andtheoriginalpreparationalreadyapprovedinChina,

6）  Drugsubstanceorpreparationfollowingnationalstandard.

II  ApplicationDossierItems

  ASummary

1）  Nameofthedrugs.

2）  CertifiedDocuments.

3）  ObjectivesandbasisforR&D.

4）  Summaryofmainstudywork.

5）  Draftofpackaginginsert,notetothedraft,andlatestliterature.

6）  Designofpackagingandlabeling.

B  Pharmaceuticaldata

7）  SummaryofPharmaceuticalStudy,

8）  Researchinformationandrelevantliteratureoftheproductionprocessofthedrugsubstance,researchinformationandrelevantliteratureofformulaandprocessofthepreparations.

9）  Studyinformationandrelevantliteratureforthechemicalstructureandcomponentsdetermination.

10）  Studyinformationandliteratureforqualityspecification.

11）  Draftofqualityspecificationandnotes,andprovidingreferencestandard.

12）  Testreportofdrugsample.

13）  Thesource,testreportandqualityspecificationofdrugsubstanceandexcipient.

14）  Stabilitystudyandrelevantliterature.

15）  Selectionbasisandqualityspecificationofimmediatepackingmaterialandcontainer.

C  Pharmacologyandtoxicologystudyinformation.

16）  Summaryofpharmacologyandtoxicologystudy.

17）  Primarypharmacodynamicsstudyandliterature.

18）  GeneralPharmacologystudyandliterature.

19）  Acute/singledosetoxicitystudyandliterature.

20）  Repeateddosetoxicitystudyandliterature.

21）  Specialsafetystudyandliteratureofhypersensitive（topical,systemicandphoto-toxicity）,hemolyticandtopicalirritative（bloodvessel,skin,mucousmembrane,andmuscle）reactionrelatedtotopicalandsystemicuseofthedrugs.

22）  StudyandrelevantliteratureonPharmacodynamics,toxicityandpharmacokineticschangecausedbytheinteractionsamongstmultiplecomponentsinthecombinationproducts.

23）  Studyandliteratureofmutagenicitytest.

24）  Studyandliteratureofreproductivetoxicity.

25）  Studyandliteratureofcarcinogenicitytest.

26）  Studyandliteratureofdrugdependence.

27）  Studyandliteratureofpre-clinicalpharmacokinetics.

D  ClinicalStudyInformation

28）  Summaryofglobalclinicalstudyinformation.

29）  Clinicalstudyprotocol.

30）  Investigator’sBrochure.

31）  DraftofInformedConsentForm,approvaloftheEthicsCommittee.

32）  Clinicalstudyreport.

III    NotestoApplicationInformationItems

1）  InformationItem1,Nameofthedrugs,includesInternationalNonproprietaryName（INN）,ChemicalName,EnglishName,andChinesePhonetics.Chemicalstructure,MolecularWeight,MolecularFormulashallbenoted.TheNomenclatureofthedrugshouldbeexplainedforanynewname.

2）  InformationItem2,CertifiedDocuments,includes,

i.  CertifiedDocumentsoflawfulregistrationoftheApplicant,copiesofDrugManufacturingLicense,GMPCertificate.Fortheapplicationofproductionofnewdrugs,copiesofGMPCertificatefortheworkshopwherethesampleproductofthedrugswasmanufacturedshouldbeprovided.

ii.  CertifiedDocumentsstatingpatentstatusandownershipofthisentityandformula,productionprocessofthedrug,andletterofguaranteestatingthatnoinfringementuponthepatentrightsofothers.

iii.  Copiesofofficialapprovalsoftheresearchproposalofnarcotics,psychotropic,medical-usetoxicdrugsandradioactivedrugs.

iv.  Fortheapplicationofproductionofnewdrugs,copyofApprovalofClinicalStudyofNewDrugsandthequalitystandardofinvestigationaldrugsshouldbeprovidedforthemarketauthorizationapproval.

v.  Fortheapplicationofproductionofpreparation,certifieddocumentstoevidencethelegalchannelsofdrugsubstanceshouldbeprovided,includingcopiesofcertifiedapprovaldocumentofdrugsubstance,drugstandards,testreport,businesslicensesofmanufacturersofdrugsubstance,DrugManufacturingLicense,GMPCertificate,salesinvoice,andsupplycontract.

vi.  CopiesoftheDrugPackingMaterialandContainerCertificateorImportDrugPackingMaterialandContainerCertificatefortheimmediatepackingmaterialandcontainer.

3）  InformationItem3,objectivesandbasisoftheapplication,includesR&D,marketingstatus,andtherelatedliteratureofthedrugs,aswellasthesummaryoftheuseandproductionofthedrugs,domesticallyandoverseas,

4）  InformationItem4,summaryandevaluationofmainresearchresults,includesthesummaryofmainresearchresultsbytheApplicant,andacomprehensiveanalysisofsafety,efficacy,andqualitycontrollabilityofthedrugsoftheapplication.

5）  InformationItem5,draftofinsertsheet,notestothedraftandlatestliterature,includesthesampleofdraftofpackaginginsertsheetdraftedinaccordancewiththerelevantregulations,notesonhoweachitemsoftheinsertsheetweredrafted,latestrelevantliterature.

6）  InformationItem7,SummaryofPharmaceuticalStudy,referstothesummaryofexperimentandgloballiteratureofPharmaceuticalStudyofthedrugintheapplication（synthesisprocess,selectionofdosageform,screeningofformula,determinationofstructure,qualitystudyanddeterminationofqualitystandards,andstabilitystudy）.

7）  InformationItem8,researchinformationoftheproductionprocessofthedrugsubstance,includestechnologyprocessandchemicalreactionequation,initialrawmaterialandorganicmenstruum,reactionconditions（temperature,pressure,duration,catalyst）andoperationprocedure,refiningmethodandmainphysical-chemicalconstants.Therawmaterialinput,andoutputyield,aswellaspossibleimpuritiesorotherby-productsproducedormixedduringtheproductionprocessshouldbeexplained.

8）  InformationItem10,experimentsinformationandliteratureforqualityresearch,includesphysical-chemicalproperties,purityinspection,dissolution,assay,andmethodologyvalidation,aswellasthedataandresultscollectedatvariousstages.

9）  InformationItem11,draftofdrugqualityspecificationandnotes,andreferencestandardshallbeprovided:

QualityspecificationshallcomplywiththeformatofthecurrentversionofChinesePharmacopoeia,andtheterminologyandunitsofmeasureofChinesePharmacopoeiashouldbeused.Reagents,reagentsolution,buffersolution,titrantandothersusedandtheirconcentrationshouldfollowthecurrentversionofChinesePharmacopoeia.Intheeventofadifferentonewasused,detailedexplanationsshouldbeprovided.Referencestandardshallbeprovidedwithseparateinformationattachedtoexplainthesource,physical-chemicalconstants,purity,content,andmeasurementmethodanddataofthedrugs.

Notestothedraftofdrugstandardsshallincludetheselectionofitemstobecontrolled,selectionofmethod,inspectionandpurityandlimitationrange,aswellasthebasistodecideeachitem.

10）  InformationItem12,thetestreportofthesampleproducts,meanstheself-testreportofthesampleproductsofthedrugsintheapplication.Self-testreportforatleastonebatchofsampleproductshouldbeprovidedbeforetheclinicalstudy.Self-testreportsoftheconsecutive3batchesofsampleproductsshouldbeprovidedforthemarketauthorizationapprovalaftercompletionoftheclinicalstudy.

11）  Informationitem14,experimentsinformationandliteratureofthestabilitystudyofthedrugs,includesstabilitytestconductedtogetherwiththeuseoftheimmediatepackingmaterialandcontainer.

12）  Informationitem16,Summaryofpharmacologyandtoxicologystudy,referstothesummaryofexperimentandgloballiteratureofpharmacologyandtoxicologystudyofthedrugintheapplication（includingpharmacodynamics,mechanismofaction,generalpharmacologyandtoxicology,andpharmacokinetics）.

13）  Informationitem27,summaryofpre-clinicalpharmacokinetics,refertothesummaryofexperimentandliteratureofpre-clinicalpharmacokinetics（animal）ofthedruginapplication（absorption,metabolite,distribution,execration）

14）  Informationitem28,Summaryofglobalclinicalstudyinformation,referstosummaryofgloballiterature,abstractandlatestupdatingregardingtheclinicaltrialofthedrugintheapplication.

15）  Informationitem29,Clinicalstudyprotocol:

Clinicalstudyprotocolshouldcoverdetailsto