Study Group on Unapproved and Off-label Drugs of High Medical Need

Published by IRDiRC

Early Access SupportScientific AdviceMHLW or PMDA RegulatoryRegulatory Affairs

The objective of the Study Group is to evaluate medical need, investigate necessary studies for market approval, and request company to develop medicinal products to solve the problem of unapproved drug and off- label use with medical need. Public consultations are conducted to gather requests from public.

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