Risk Management Plan | Risk management plan

A” Risk Management Plan (RMP)” is a document to assess the benefit-risk balance of a drug to prevent or minimize medication risks. TFDA introduced this ...回首頁網站導覽中文版English藥品醫療器材諮詢輔導醫療科技評估國際合作中心簡介藥品審查提供藥品技術性資料評估，以確保用藥的品質、安全與療效。

NewDrug首頁藥品審查NewDrugNewDrugRiskManagementPlanA”RiskManagementPlan(RMP)”isadocumenttoassessthebenefit-riskbalanceofadrugtopreventorminimizemedicationrisks.TFDAintroducedthisregulatoryregimebyreferencetotheadvancedcountries,suchastheUSFDAandEMA.RMPsnormallyincludemedicationguides,communicationplans,riskmitigationmeasures,etc.Itshouldberegularlymodifiedandupdatedduringthewholemedicinelifecycle.The“GuidelineontheRiskManagementPlanandtheFormat”wasissuedonApril5,2012,toassistpharmaceuticalcompaniesforpreparationofRMPandensuringfurtherrisk-minimizationmeasures.AccordingtoArticle38-1oftheRegulationsforRegistrationofMedicinalProducts,anRMPisrequiredforanapplicationofNCE(NewChemicalEntity)withnon-CPPordomesticNCE.OthernewdrugsormarketedmedicinesmayberequestedtosubmitRMPsbasedonthedrugsafetyassessmentwiththedifferentlevelsofrisk.ThefollowinginformationintroducesthesubmissionofRMPs.PleasefindmoreinformationaboutNDAsubmissionsatRulesandRegulationsorvisitthewebsitePharmaceuticalRegulationsinTaiwan.Ⅰ.CLASSIFICATIONS1.Riskmanagementplananditspost-approvalchanges2.RiskmanagementplanassessmentreportⅡ.SUBMISSIONREQUIREMENTS1.Riskmanagementplan：Acoverlettertostaterationaleforapplication,andariskmanagementplan2.Post-approvalchangesofRMP：Acoverlettertostaterationaleforapplication,thelatestapprovedRMPwiththeversionnumberanddate,anupdatedRMP,andacomparisontabletoindicatethedifferencebetweenthecurrentversionandtheproposedversionoftheRMP.3.Riskmanagementplanassessmentreport：Acoverlettertostaterationaleforapplication,thelatestapprovedRMPwiththeversionnumberanddate,andanRMPassessmentreport.III.NOTICEBEFORESUBMISSION1.Allnon-CPPNCEordomesticNCEapplicationsmusthaveanaccompanyingRMPsubmission.2.Post-approvalrevisionsoftheRMPshouldbesubmittedforassessmentandapprovalb

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