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

Published by IRDiRC

Regulatory AffairsEarly Access SupportScientific AdviceMHLW or PMDA Regulatory

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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Interaction of the stakeholders and multilateral education at an early stage of development will facilitate drug development (e.g. ensuring outcome measures for clinical trials are developed that are meaningful for patients, are acceptable to the regulators, and are acceptable to payers)

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