Conditional and Time-limited Authorization of Regenerative Medical Products

Published by IRDiRC

Regulatory AffairsMarketing AuthorisationAdvanced Therapy ProcedureMHLW or PMDA Regenerative Medical ProductsPMD ActCTARP

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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