2-1-WHO-PQ认证指导原则及提交资料的格式要求-2013.06(英文)

GuidelineonSubmissionofDocumentationandPreparationofProductDossierHuaYINWHOPrequalificationProgramme–Nanning,June201322Abbreviations•PQP:PrequalificaitonofMedicinesProgramme•API:ActivePharmaceuticalIngredient•FPP:FinishedPharmaceuticalProduct•APIMF:ActivePharmaceuticalIngredientMasterFile(DMF)•SRA:StringentRegulatoryAuthorities•CEP:CertificateofSuitability(CoS)•QOS-PD:QualityOverallSummary-ProductDossier•QIS:QualityInformationSummary•FDC:Fixeddosecombination•CTD:Commontechnicaldocument33Overview•WHOPQPGuidelines•GenericGuideline–ThePreparationGuideline–TheQualityGuideline•Structureofqualitymodule–CTDformat–QOS-PD:qualityoverallsummary–QIS:qualityinformationsummary4(Quality)GenericGuideline•Guidelineonsubmissionofdocumentationforamultisource(Generic)FinishedPharmaceuticalProduct(FPP):PreparationofPrequalificationProductDossierinCTDFormat•GuidelineonsubmissionofdocumentationforamultisourceFPP:QualityPart7PrequalificationGuidelines(Quality)•Innovators—GuideonsubmissionofdocumentationforprequalificationofinnovatorFPPapprovedbyStringentregulatoryauthorities•PrequalificationofgenericproductsapprovedbyStringentRegulatoryAuthorities(SRAs)78PrequalificationGuidelines(Quality)•Guidelinesonactivepharmaceuticalingredientmasterfileprocedure•Guidelinesforregistrationoffixed-dosecombinationmedicinalproducts•Guidanceonvariationstoaprequalifiedproduct-new•Guidelinesontherequalificationofprequalifieddossiers9PrequalificationGuidelines(Quality)•Questions&Answersonzincapplications•TheWHOprequalificationofMedicinesprocedureforintroductionofasourceofnon-plant-derived-artemisinin--new•GuidancenotetoApplicants(Manufacturers)onthecompilationoftheWHOPublicAssessmentReport(WHOPAR),includes−SummaryofProductCharacteristics(SPC)−PatientInformationLeaflet(PIL)−Labelling910PrequalificationGuidelines(BE)•Bioequivalencestudies–Guidelines,relatedtobioequivalencestudies–Glossaryonbioequivalence–Comparatorproducts–Biowaiverimplementation–Adviceonthedesignofbioequivalencestudies•GuidanceonBioequivalencestudiesforreproductivehealthmedicines•ContractResearchOrganizations(CROs)11Nanning,June2013(Quality)WhenWHOorPQguidelinessilent•ICHguidance:–Q2(R1):ValidationofAnalyticalProcedures–Q3A(R2).Impuritiesinnewdrugsubstances–Q3B(R2).Impuritiesinnewdrugproducts–Q3C(R3).Impurities:Guidelineforresidualsolvents–Q6A.Specifications•Otheragencies'requirements,suchas–USFDA:SUPAC,permittedcolorants–EMA:EUlimitsofgenotoxicimpurities1213Genericguideline•Guidelineonsubmissionofdocumentationforamultisource(Generic)FinishedPharmaceuticalProduct(FPP):PreparationofPrequalificationProductDossierinCTDFormat•GuidelineonsubmissionofdocumentationforamultisourceFPP:QualityPart–QualityOverallSummary-ProductDossier(QOS-PD)–QualityInformationSummary(QIS)1414Genericguideline•FullyadoptICH'sCommonTechnicalDocument(CTD)structure,includingQualityOverallSummary(QOS)•Harmonize,wherepossible,withinternationallyacceptedstandards(e.g.ICH)•Provideclearandtransparentguidancetoapplicantsforpreparingandsubmittingthesedossiersandfacilitatethesubsequentassessment;•Updateguidelinestoreflectcurrenttechnicalrequirementsforprequalificationproductdossiers15IntroductiontotheTwoDocumentsI:ThePreparationGuideline•Providesgeneralguidanceontheformatforpreparationandorganisationofdossiers;•DescribesandadoptsthemodularformatoftheCTD•Providesguidanceonthelocationofregionalinformation(Module1)andothergeneraldatarequirements.•Isnotintendedtoindicatethetechnicalrequirements.1516CTD-triangleRegionalAdminInformationModule1NonclinicalOverviewNonclinicalSummaryClinicalSummaryNonclinicalStudyReportsModule4ClinicalReportsModule5QualityModule3ClinicalOverviewQualityOverallSummaryModule2NotPartoftheCTDTheCTD17AdaptingtheCTD-newdrugtoCTD-genericRegionalAdminInformationModule1BioEquivStudyReportsModule5QualityModule3QualityOverallSummaryModule2NotPartoftheCTDTheCTD1818CTDStructure-Modules•Module1-AdministrativeandPrescribinginformation–Reginonspecific•Module2–QualityOverallSummary–QOS-PD•Module3-Quality•Module5–BioequivalentstudyReports(orbiawaiver)19Module1–Administrativeinformationandprescribinginformation(WHOPQP)1.0Coverletter1.1TableofcontentsoftheapplicationincludingModule1(Modules1-5)1.2Applicationinformation:Certificates,suchas:–Manufacturingandmarketingauthorization(s)–CEP–Lettersofaccess–GMPCertificate1920Module1–Administrativeinformationandprescribinginformation1.3Productinformation:1.3.1Summaryofproductcharacteristics(SmPC)1.3.2Packageleaflet(patientinformationleaflet--PIL)1.3.3Labelling(outerandinnerlabels)1.4Regionalsummaries:1.4.1BioequivalenceTrialInformationForm(BTIF)1.4.2Qualityinformationsummary(QIS)2021IntroductiontotheTwoDocumentsII:TheQualityGuideline•ProvidesguidanceontheQualityModuleofProductDossiersbyadoptingthemodularformatoftheCTD3.2.SDrugsubstance(orAPI),and,3.2.PDrugproduct(orFPP)•Presentationofthedataisdescribedforvariousscenarios,e.g.,multipleAPIs,multipleFPPstren