A new analysis of orphan drug approvals across six global regulatory regions highlights significant delays in access to innovative therapies for people living with rare diseases. The study, conducted by the International Rare Diseases Research Consortium (IRDiRC) Regulatory Science Committee (RSC), examined all new non-oncology orphan medicines approved between 2021 and 2022 and found substantial […]
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The Changing Focus of Regulatory Frameworks Around the Globe and the Opportunities for Harmonization
IRDiRC is proud to share that Regulatory Scientific Committee Vice Chair, Violeta Stoyanova-Beninska, is one of the guest editors of the research topic “The Changing Focus of Regulatory Frameworks Around the Globe and the Opportunities for Harmonization” in Frontiers in Medicine. As regulation related to the development, registration and monitoring of medicinal products is at […]
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