Overview
- The MHRA published its Strategy to 2030 on Wednesday, October 14, 2026, committing near-term service targets such as a premium scientific advice service cut from 90 days to 45 days and halving the Phase 1 initial assessment target to 14 days.
- The agency will create an MHRA Centre for AI and Digital Health and publish an AI Medicines Development Action Plan in 2027, and it will build tools such as an AI-enabled Clinical Trial Protocol Checker to raise application quality and speed reviews.
- The strategy expands the regulator’s use of real‑world data by improving access to hospital and genomics records and by working with the Health Data Research Service to enable faster safety signal detection and simpler Yellow Card reporting.
- MHRA says it will support innovation through measures like a voucher scheme for start-ups, promotion of non-animal test methods, and a flexible risk‑proportionate approach for rare disease therapies while sharply increasing criminal enforcement and work with online platforms to tackle illegal medicines.
- The plan builds on recent reforms to clinical trials rules and stresses international cooperation with regulators including the US FDA and the Access Consortium to cut duplication and speed patient access to new treatments.