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.
View this resource Bookmark this resource
Japanese Orphan Drugs/Medical Devices/Regenerative Medical Products Designation
Published by IRDiRC
Research and Drug DevelopmentRegulatory AffairsEarly Access SupportOrphan Drug DesignationOrphan Drug or Medical Device DesignationMHLW or PMDA RegulatoryMHLWMedical ProductJ-ODD