Regulatory Science

The information proposed in this section provides key elements on the regulation of medicines for Rare Diseases in human and provides support in the:
Health Technology Assessment,
Drug repurposing,
Preclinical suties,
Early access support,
Clinical Development,
Marketing Authorization,
Ethic and legal issues,
Regulatory Agencies.

  1. Showing 11 results for:
  2. Regulatory Science
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Conditional and Time-limited Authorization of Regenerative Medical Products

Published by IRDiRC

Advanced Therapy ProcedureCTARPMarketing AuthorisationMHLW or PMDA Regenerative Medical ProductsPMD ActRegulatory Affairs

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

Published by IRDiRC

Early Access SupportMHLW or PMDA RegulatoryRegulatory AffairsScientific Advice

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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