Marketing Authorization under Exceptional circumstances

Published by IRDiRC

Marketing AuthorisationRegulatory AffairsExceptional Circumstance

The MAUEC enables the marketing authorization of medicines for which the applicant would otherwise be unable to provide comprehensive data on the efficacy and Safety under normal conditions due to reasons of extreme rarity of the condition, technical impossibility to generate comprehensive knowledge, or ethical constraints.

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Conditional and Time-limited Authorization of Regenerative Medical Products

Published by IRDiRC

CTARPRegulatory AffairsMarketing AuthorisationAdvanced Therapy ProcedureMHLW or PMDA Regenerative Medical ProductsPMD Act

A regulatory framework for the approval of regenerative medical products to benefit the patients with unmet medical needs under The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)

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