Orphan Unknowns: What the MHRA Guidance Will Mean After Brexit

Developers of orphan drug products face some important changes with the approval process in the UK after Brexit. To help companies prepare, the MHRA published new guidance: “How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB)”. While most of the criteria to qualify for orphan drug designation align […]

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