This program grants a voucher for priority review from the US Food and Drug Administration (FDA), which aim to render a decision within 6 months (in contrast to 10 for a standard review). The developed drug for which the voucher is awarded must be intended for a rare disease or condition and that primarily affect individuals from 0 to 18 years. The voucher can be utilized for any other drug development program.

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Follow the journey of a medicine for human use assessed by EMA in this interactive timeline. It explains all stages from initial research to patient access, including how EMA supports medicine development, assesses the benefits and risks and monitors the Safety of medicines. 

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Marketing Authorization under Exceptional circumstances

Published by IRDiRC

Regulatory AffairsMarketing AuthorisationExceptional 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

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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