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.

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  2. Regulatory Science
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Japanese Orphan Drugs/Medical Devices/Regenerative Medical Products Designation

Published by IRDiRC

Early Access SupportJ-ODDMedical ProductMHLWMHLW or PMDA RegulatoryOrphan Drug DesignationOrphan Drug or Medical Device DesignationRegulatory AffairsResearch and Drug Development

In Japan, drugs, medical devices, and regenerative medical products can be designated as orphan drugs, medical devices, or regenerative medical products based on the Article 77-2 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics if they are intended for use in basically less than 50 000 patients in Japan and for which there is a high medical need.

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EMA Priority Medicines -PRIME scheme

Published by IRDiRC

Early Access SupportEarly ApprovalPriority Medicines SchemeRegulatory Affairs

PRIME supports developers of medicines addressing an unmet medical need or which may bring major therapeutic advantage to patient with enhanced interaction and early dialogue to optimize the development of eligible medicines, improving clinical trial designs and speed up their evaluation and contribute to timely patients’ access. PRIME builds on the existing regulatory framework and tools already available such as scientific advice and accelerated assessment.

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