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- 2026-09-19 发布于重庆
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药品风险管理计划-案例分析药品风险管理计划-案例分析FDARiskMinimisationActionPlan(MAP)initiative,whilstbroadlybasedonICHE2E,doesappeartoimposesomeUS-specificrequirementsarounddocumentformatandthereisastrongemphasisonsafetyrisksintheperi-approvalperiod.EUdraftguidancewascirculatedforcommentbytheindustryinOctober2005andinputbyAZwasprovided.Commentsweresubmittedon18thOctober2005andaresponsefromtheEMEAisawaited.OtherNationalRequirements:Somenationalauthorities(e.g.Netherlands,UK)havealreadyrequestedPRMPsforsomeproductsandhaveindicat
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