WHO -世界卫生组织模型风险管理计划标准操作程序 WHO Model RMP Standard Operating Procedure (SOP)

SOPonRMPAssessment–CustomisableforspecificcountryNRAs.Page1

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WHOMODELRMPASSESSMENT

STANDARDOPERATIONPROCEDURE(SOP)

31OCTOBER2025

NameofProcedure

ManagementandreviewofRiskManagementPlan(RMP)

DocumentNumber

Preparedby

Authorisedby

Effectivedate

1.OBJECTIVE

ThepurposeofthisStandardOperatingProcedure(SOP)istoprovideclearinstructionsforstafresponsibleforreviewingandmanagingRiskManagementPlans(RMPs).ItoutlinestheprocessforassessingRMPsandimplementingassessmentoutcomes.TheSOPalsodetailstheproceduresforreceiving,administrativelyprocessingandevaluatingRMPs.

2.SCOPE

ThescopeofthisProcedureincludesRiskManagementPlans(RMPs)submittedbyMarketAuthorisationHolders(MAHs),RMPsapprovedbyareferenceorganization,e.g.WHO-ListedAuthority(WLA)orelaboratedinthecontextofWHOPre-Qualification(PQ)aswellasotherRMP-relevantdocumentsusedasalternativewheneverthesearenotaccessibleornotapprovedbyreferenceorganizations.TheProceduremaybeusedforinitialapplicationforMarketAuthorisation(MA),newsubmission/changeinRMP,aswellasMArenewal.

3.CROSS-REFERENCES

TheWHOModelRiskManagementPlanAssessmentGuidelines(Annex1)andAssessmentTemplate(Annex2)areusedinassessingtheRMPdescribedinthisSOP.(Addanyotherreferenceshere.)

4.DEFINITIONS

RMP

RiskManagementPlan

WLA

WHO-ListedAuthority

PSUR

PeriodicSafetyUpdateReport

MAH

MarketingAuthorizationHolder

5.RESPONSIBILITIES

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TheHeadoftheRegistrationUnitisresponsibleformaintainingandoverseeingthisSOP.RMPreviewersareresponsibleforensuringthattheproceduresandrelateddocuments,includingtheRMPAssessmentGuidelinesandTemplates,arekeptuptodate.

HeadoftheRegistrationUnit

•DesignatetechnicalofficerstoreviewanRMP.

•ApprovetheRMPassessmentreportandconfirmifanyregulatoryactionsneedtobetaken.

•MaintainthisSOP

Headofthe

PharmacovigilanceUnit

•DesignatetechnicalofficerstoreviewanRMP.

•ProvidefeedbackontheRMPassessmentreport

RMPReviewer

•ReviewtheRMPdocumentsandsubmittheRMPAssessmentReportforinternaldiscussionandapproval

RMPCoordinator

•ArchiveandmaintaintheRMPtrackingsheet

6.HIGHLEVELFLOWCHART

7.PROCESS

7.1.SubmissionofRMPDocuments

TheMarketingAuthorizationHolder(MAH)shallsubmitRiskManagementPlan(RMP)documentselectronicallyto[NameofNRA]aspartofthemarketingauthorizationapplication.

•ThesubmissionmustfollowtheNRA’sprescribedelectronicformatandincludeallrelevantmodules,appendices,andsupportingdata.

•TheMAHmayalsosubmitanRMPwhennewlyrequestedbytheNRA,orupdatedorrevisedRMPspost-authorizationwhennewsafetyinformationbecomesavailableoruponrequestbytheNRA.

7.2.ScreeningandAcknowledgementofReceipt

TheRMPCoordinatorisresponsibleforscreeningallincomingRMPsubmissionstoensurecompletenessandcompliancewiththerequiredformat.

•Incompleteornon-compliantsubmissionsshallbereturnedtotheMAHforcorrection.

•Uponconfirmingreceiptofacompletedossier,theRMPCoordinatorshallissueanacknowledgementletteroremailtotheMAH,confirmingsuccessfulsubmissionandrecordingthedateofreceipt.

7.3.TrackingandAssignmentTimeline

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TheRMPCoordinatorshallrecordandmonitorthetimelineforreview.

•TheexpectedreviewduedatemustbeclearlyindicatedonthecoverpageortrackingformoftheRMPapplication.

•Thistrackingensurestimelyallocation,review,andreportinginaccordancewiththeinternalperformancestandardsorSOPtimelines.

7.4.AllocationofReviewers

TheRMPCoordinatorshallforwardthevalidatedRMPdossierto[NameoftheresponsibleMAorPVunit]forreviewerassignment.

•Allocationshallconsiderexpertise,workloadbalance,andproducttype(e.g.,vaccine,biologic,generic,newchemicalentity).

•TheRMPCoordinatormaintainsalogofreviewerassignmentsforaccountabilityandtraceability.

7.5.ReviewandAssessment

ThedesignatedRMPreviewersshallassesstheRMPfollowingtheRMPAssessmentGuidelinesandTemplates.

•TheassessmentshouldcovertheSafetySpecification,PharmacovigilancePlan,andRiskMinimizationPlan,asapplicablefocusingonnon-routinemethodsandmeasures.

•ReviewersshallprepareandsubmitanRMPAssessmentReporttotheHeadoftheirUnitwithinthedefinedreviewperiod.

7.6.FinalizationofAssessmentReport

TheHeadofthe[PharmacovigilanceUnitorRegistrationUnit]shallconsolidatereviewerinputsandfinalizetheRMPAssessmentReport.

•ThefinalizedreportshallthenbesubmittedtotheHeadofthe[PharmacovigilanceUnitorRegistrationUnit]forreview,finalconclusions,andregulatoryrecommendations(e.g.,approval,requestforrevision,orrejection).

7.7.ArchivingFinalReport

TheRMPCoordinatorisresponsibleformaintainingproperdocumentationandarchivingthefinalapprovedassessmentreportandallrelatedcorrespondenceinbothelectronicandphysicalformatsaccordingtothe[NameoftheNRA]’sdocumentretentionpolicy.

7.8.CommunicationtotheMAH

TheRMPCoordinatorshallissueanofficialcommunicationtotheMAHontheoutcomeoftheRMPassessment.

•TheRMPCoordinatorcommunicateswiththeMAHifthereareanyqueriestoclarify.

•Thelettershallclearlyoutlineanyriskmanagementcommitments,follow-upactions,orconditionsimposedaspartofthemarketingauthorization.

•TheRMPCoordinatorensuresthatallcommunicationsareloggedandstoredforfuturereference.

7.9.ImplementationofAdditionalPharmacovigilanceActivities

Ifdeemednecessary,theHeadofthePharmacovigilanceUnitshallinitiateorcoordinateadditionalpharmacovigilanceactivitiestofurthermonitor,evaluate,ormitigateidentifiedrisks.

•Suchactivitiesmayincludeenhancedadverseeventmonitoring,targetedpost-authorizationstudies(PASS),orrisk-minimizationinterventions.

•Outcomesofthe