艾昆玮档案提交更新：马来西亚卫生部药品上市第三版的关键变化（英）2024

UpdatesforDossierSubmission:KeyChangesinthe3rdEditionforListingMedicineswiththeMalaysiaMinistryofHealth SummaryofChanges C|UpdatesforDossierSubmission:KeyChangesinthe3rdEditionforListingMedicineswiththeMalaysiaMinistryofHealth Tableofcontents Summaryofchanges1 Listingworkflow2 Typesofdossierforms3 Emailandmailingaddress3 Intentiontosubmit4 Dossierformatting6 Dossierarrangement(hardcopy)7 Submissionformat(hardcopyvs.softcopy)8 DossierD1checklistandDossierD1form8 DossierD2checklistandDossierD2form9 Medicinepricedeclarationform9 Applicantstatementofdeclaration9 Supportingclinicalevidence10 Supportingeconomicevidence10 Provisionofone-yearutilisationdatapost-listing10 Appendix:Workflow11 Listofabbreviations12 Glossary13 References14 Authors14 AboutIQVIAAsiaPacific14 Summaryofchanges No. Item Change 1 Listingworkflow Updatesondurationofeachprocessingstage 2 Typeofdossierforms Changesintypesofdossierforms 3 Emailandmailingaddress Changesinaddress 4 Intentiontosubmit Newinstructions 5 Dossierformatting Additionalinstructions 6 Dossierarrangement(hardcopy) Newinstructions 7 Submissionformat(hardcopyvs.softcopy) Newinstructions 8 DossierD1checklistandDossierD1form Changesincontents 9 DossierD2checklistandDossierD2form Changesincontents 10 Medicinepricedeclarationform Nochangesincontent 11 Applicationstatementofdeclaration Additionalclauses 12 Supportingclinicalevidence Nochanges 13 Supportingeconomicevidence Nochanges 14 Provisionofone-yearutilisationdatapost-listing Newrequirement 15 Appendix:Workflow Updatesondurationofeachprocessingstage Listingworkflow Updatesonthedurationofeachprocessingstage •Specifictimelinesforeachprocessingstagehavebeenupdatedinthe3rdeditionoftheGuideline. •Belowisacomparisonbetweenthe2ndandthe3rdeditionoftheGuideline.ReferAppendix:Workflowforwork processflowchart. 2NDEDITIONOFTHEGUIDELINE 3RDEDITIONOFTHEGUIDELINE Dossiercompletenessscreeningtimeline Notexplicitlystated ScreeningforcompletenessofdocumenttobecompletedwithinsevendaysofreceivingdocumentsfromPRH BIAscreeningtimeline Notexplicitlystated Screeningsetat90workingdays,excludingstopclockforobtainingfeedbacksfromstakeholdersandapplicant.Amaximumofthreecorrespondenceisallowedduringscreening •IfBIA/CEisnotsatisfactory,apostsubmissionmeeting maybeofferedtodiscusstheissuesinvolved •However,thedossierwillbeconsideredincompleteandwillberejectedbytheSecretariatifitisstillnotsatisfactory•Theapplicantmayneedtoresubmitthedossieraftercooling-offperiodofthreemonthsalongwithpreviouscommentsandchangesinthemodel Paymenttimeline Paymenttobemadeupondossiersubmission Paymenttobemadewithin15workingdaysafterdateofscreeningapproval(completenessofdocumentandcompletionofBIAscreening)Officialreceiptwillbeissuedwithinfiveworkingdays Dossierevaluationtimeline Evaluationwillbeperformedandcompletedwithin120calendardays. Uponconfirmationofpayment,dossiershallbeevaluatedandcompletedwithin90workingdays OutcomeofMOHMFReviewPanelMeeting PRHtobenotifiedonoutcomewithin15workingdays PRHtobenotifiedonoutcomewithinthreeworkingdays ListofnotificationstoPRH Notexplicitlystated •Acceptanceofdossier•BIAscreeningstartdate(forDossierD1) •Screeningapprovalandpaymentinstruction(applicableforsubmissionbyPRH) •Officialpaymentreceiptandevaluationnotification•Completionofdossierevaluation •PresentationofdossierintheMOHMFpanelmeeting(within30daysbeforethemeeting)•DecisionoftheMOHMFpanel(withinthreeworkingdaysfromthedateofmeeting) Abbreviations:BIA,BudgetImpactAnalysis;CE,Cost-effectiveness;MOHMF,MinistryofHealthMedicinesFormulary;PRH,Productregistrationholder Typesofdossierforms Changesintypesofdossierforms •The3rdeditionoftheGuidelinecontainsonlyfourtypesofdossierforms,asopposedtothe2ndeditionofthe Guideline,whichhasfive. •Belowisacomparisonbetweenthe2ndandthe3rdeditionoftheGuideline. FORM 2NDEDITIONOFTHEGUIDELINE 3RDEDITIONOFTHEGUIDELINE D1 •TolistnewmedicinesintoMOHMFortolistnewindicationforexistingmedicinesbyPRHonly •Oneindicationperdossier •TolistnewmedicinesintoMOHMFortolistnewindicationby PRH,DWC**andMOH** •Onemedicineorindicationperdossier •If>1indicationforonemedicine,separatedossierrequired(Refertopg.71oftheGuideline) D2 •Toadddosageform/strengthlistedinMOHMFbyPRHonly •Toadddosageform/strengthlistedinMOHMFbyPRH,DWC**andMOH** D3 •TochangecategoryofprescriberbyMOHonly •Nochanges D4 •Tolistnewmedicinesintoinstitution’smedicinesformularybyMOHonly •TodelistapprovedmedicineorindicationfromMOHMFbyMOHonly •PRHcannolongersubmit(seepg.69ofGuideline) D5 •TodelistapprovedmedicineorindicationfromMOHMFbyPRHorMOH •ReferD4fordelisting•D5nolongerapplicable Abbreviations:DWC,DrugWorkingCommittee;MOH,MinistryofHealth;MOHMF,MinistryofHealthMedicinesFormulary;PRH,Productregistrationholder **MOHDWC&otherprogramme/divisioninMOHareallowedtosubmitthesetypesofdossiersformultisourcemedicinesonly. Multisourcemedicinesrefertopharmaceuticallyequivalentorpharmaceuticallyalternativeproductsthatmayormaynotbetherapeuticallyequivalent.Multisourcepharmaceuticalproductsthataretherapeuticallyequivale