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.