Published by IRDiRC
Regulatory AffairsEarly Access SupportOrphan Drug DesignationEU orphan legislation offers important incentives to encourage the development of medicinal products for rare diseases and the success of the legislation has been demonstrate
View this resource Bookmark this resourcePublished by n/a
Scientic adviceEATRISRegulatory SupportOrphan Drug DesignationThrough a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product including: Expert opinion, Orphan Drug Designation and Scientific Advice application at the EMA, Pre-clinical and clinical plan development, Informal scientific advice with selected national competent authorities, for highly complex projects,
access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.
Published by IRDiRC
Regulatory AffairsEarly Access SupportOrphan Drug DesignationEU orphan legislation offers important incentives to encourage the development of medicinal products for rare diseases and the success of the legislation has been demonstrate
View this resource Bookmark this resourcePublished by IRDiRC
Orphan Drug DesignationRegulatory AffairsEarly Access SupportRegulatory AdviceOrphan Drug IncentiveThe ODA is intended to provide incentives for Orphan Drug development and to defray the costs of qualified clinical testing expenses incurred in connection with the development of drugs for rare diseases and conditions.
View this resource Bookmark this resourcePublished by IRDiRC
Regulatory AffairsEarly Access SupportPaediatric MedicineOrphan Drug DesignationRare Paediatric Disease DesignationThe FDA grants rare pediatric disease designation for diseases with serious or life- threatening conditions that affect people from birth to 18 years of age, that affect fewer than 200,000 people in the U.S.
View this resource Bookmark this resourcePublished by IRDiRC
MHLW or PMDA RegulatoryJ-ODDMedical ProductResearch and Drug DevelopmentMHLWOrphan Drug or Medical Device DesignationOrphan Drug DesignationEarly Access SupportRegulatory AffairsIn 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
