Alliance for mRNA submits comments on MHRA’s proposed Rare Disease Framework
On July 30, 2026, the Alliance for mRNA Medicines submitted comments to the MHRA’s Open Consultation on its proposed Rare Disease Framework. AMM’s response supports bringing more rare disease treatments into a regulated pathway that allows iterative evidence generation, and encourages a shift from a traditional, linear development model to a balanced lifecycle model. The submission emphasizes sustained patient engagement throughout the regulatory process, early and flexible regulatory engagement for developers, open trial registration and transparent data sharing, and a dynamic, lifecycle-linked approach to market exclusivity.
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Alliance for mRNA submits comments on MHRA’s proposed Rare Disease Framework
On July 30, 2026, the Alliance for mRNA Medicines submitted comments to the MHRA’s Open Consultation on its proposed Rare Disease Framework. AMM’s response supports bringing more rare disease treatments into a regulated pathway that allows iterative evidence generation, and encourages a shift from a traditional, linear development model to a balanced lifecycle model. The submission emphasizes sustained patient engagement throughout the regulatory process, early and flexible regulatory engagement for developers, open trial registration and transparent data sharing, and a dynamic, lifecycle-linked approach to market exclusivity.
Read the full submission here.