1-1-WHO-PQP总体概述和更新-2013.06(英文)

WHOPrequalificationofMedicinesProgrammeGeneraloverviewandupdateDrMilanSmidWHOPrequalificationofMedicinesProgrammeNanning,June20132Nanning,June2013UNPrequalificationProgrammeforPriorityEssentialMedicinesActionplanofUNfrom2001forexpandingaccesstoselectedprioritymedicinesObjective:•Toensurequality,efficacyandsafetyofmedicinesprocuredusinginternationalfunds(e.g.GFTAM,UNITAID)toservepatientsindevelopingcountriesComponents:•EvaluationofQuality,SafetyandEfficacyofprioritisedEssentialmedicines(FPPsandAPIs),inspectionsofmanufacturersandmonitoringoftheproductsaftertheirprequalification.•Prequalificationofqualitycontrollaboratories.•Buildingcapacityofregulators,manufacturersandqualitycontrollaboratories.3Nanning,June2013Categoriesofmedicinesinvited•Primarycategoriesofmedicines:–HIV/AIDS–Malaria–Tuberculosis•Lateradded:–Reproductivehealth–Influenza–Acutediarrhoea–Neglectedtropicaldiseases•Potentiallyothercategoriesofproducts,ifthereistheneed•PrequalificationalsoapplicableforAPIs!•PublishedininvitationsforExpressionofInterest(EOI)onPrequalificationwebsite4Nanning,June2013Example-invitedSLTBmedicines(1)5Nanning,June2013EssentialstepsofPQevaluationprocedure•NeedisspecifiedandagreedbyWHOtreatmentprogrammes•InvitationforExpressionofInterest(EOI)ispublished•Interestedpartiessubmitdossiers•Dossiersreceiveinitialscreening•Fulldossiersareassessed•InspectionsareconductedatmanufacturingsitesandatCROs•Samplesaretested,ifneeded•Ifoutcomeispositive,pharmaceuticalproductislistedonthewebsite,includingproductinformation(SPC,PIL),assessmentreport(WHOPAR)andinspectionreport(WHOPIR)6Nanning,June2013EssentialstepsofmonitoringofPQproduct•Variationstothedossierofprequalifiedproduct•SamplingandTesting•Re-inspections•Requalification•Managementofcomplaints•De-listingorsuspension(ifandwhenappropriate)7Nanning,June2013IExpressionofInterestComplianceAdditionalinformationanddataCorrectiveactionsComplianceAssessmentInspectionsStepsinWHOprequalificationPrequalificationMaintenanceandmonitoringProductdossierSMF8Nanning,June2013InvitationforexpressionofInterestDossierandSMFsubmittedforassessmentandacceptedTwoprequalificationroutesMedicineassessedbySRAMedicinenotassessedbySRAWHOassessmentandinspectionsorganizedCompliancePrequalificationAcceptanceSimplifiedreviewValidforinnovatorsandgenericsSRAregistration(assessmentandcompliancecheck)Post-PQmaintenance9Nanning,June2013Datarequestedforprequalification9APIFPPS&E++AnapplicationtoprequalifyanFPPtypicallyhasthreeparts:InformationonthepreparationandcontroloftheAPI.InformationonthepreparationandcontroloftheFPP.Safetyandefficacydata,e.g.commonlyreplacedbydemonstrationofbioequivalence10Nanning,June2013Standards•WHOstandardsasdefinedinWHOguidelinesandInternationalPharmacopoeiaareappliedinprequalificationprocess•Ifthesenotexist,ICHguidelinesareapplied•Incaseofneed,guidelinesofstringentregulatoryauthorities,whichareinvolvedinICHprocess•Pharmacopoeias(Ph.Int.,USP,BP,Ph.Eur.,JP)asminimumstandard•Dependingonproduct,assessorsmayaskforadditionaltestsortighteninglimits•Sameprinciplesappliedinprequalificationasvalidfornationalregulatoryapprovalsbystringentauthorities1011Nanning,June2013WHOguidelinesandmonographsMedicinesrelatedguidelines::!12Nanning,June2013EvaluationprocedureAssessmentofproductdossiers(Qualityspecifications,pharmaceuticaldevelopment,production,control,stability,bioequivalenceetc.).TeamsofprofessionalsfromnationalDrugRegulatoryAuthorities(DRA):IncludingBrazil,China,Canada,Denmark,Estonia,Finland,France,Germany,Hungary,Indonesia,Malaysia,Philippines,Spain,South-Africa,Sweden,Switzerland,Tanzania,Uganda,UK,Zimbabwe...Copenhagenassessmentweek•8to20assessorstogetherduringoneweekatleasteverytwomonthsatUNICEFinDenmark•Everydossierisassessedbyatleastfourassessors.•Anassessmentreportisissued-signedbyassessors•Lettersummarizingthefindingsandaskingforclarificationandadditionaldataifnecessaryissentfirstbye-mailtotheapplicantfollowedbysurfacemail13Nanning,June2013Inspections•Teamofinspectorsforeachinspection•WHOPQinspectorplusPIC/Smembercountrypluslocalcountryinspector(observer)•Somecases–capacitybuilding(recipientcountry)•Inspectionsareproductoriented•APIsandBioequivalencestudiesinspectedbasedonriskassessment•PublicinspectionreportispostedonPQPwebsite14Nanning,June2013OutcomesofPQprocedureInformationinpublicdomain:•ListsofPQmedicinalproducts•WHOPAR(SPC,PIL,labelling)•WHOPIR(bothFPPandAPI)•NoticesofConcernandSuspensions•Informationonprogressofassessmentprocedureandinspections•Supportivedocuments:WHOguidelines,descriptionofPQprocedure,trainingmaterials15Nanning,June201315(March2013)17Nanning,June2013Prequalified425medicines(March2013)99medicineslistedbasedonthe-approvaland/ortentativeapprovalbyUSFDA(95)-approvalwithinCanada'sAccesstoMedicinesRegime(1)-approvalbyEMAaccordingtoArticle