The UK MHRA published its Strategy 2030 plan for adapting regulations to AI and personalised medicine. It pledges faster and more predictable regulatory decisions. It aims to halve scientific advice time to 45 days. It will cut phase 1 trial assessment targets to 14 days. It plans an AI Medicines Development Action Plan for 2027. It seeks to improve real-world evidence generation using AI. It commits to reducing animal testing and increasing clinical trial diversity. It will launch a women’s health plan this year. It aims to close ethnic health gaps. The ABPI welcomed the strategy as matching industry ambitions.
What changed
Regulatory processes were not adapted for AI and personalised medicines.
What it unlocks
Faster regulatory decisions and quicker access to new AI-enabled treatments in the UK.
- 90 to 45 days for scientific advice
- 30 to 14 days for phase 1 trial assessment
- AI Medicines Development Action Plan in 2027
Sources