The Medicines and Healthcare products Regulatory Agency (MHRA) is initiating three projects to leverage artificial intelligence to improve medicine safety and accelerate access to treatments. Funded by the UK Government’s Regulatory Innovation Office’s AI Capability Fund, these initiatives aim to harness AI with real-world data to better predict drug interactions, guide prescribing, and strengthen regulatory decision-making.
Predicting Side Effects of Drug Combinations
The first project, with £859,650 in funding, will partner with PhaSER Biomedical and the University of Dundee to develop an AI system that analyzes anonymised NHS data to identify patterns in how medicine combinations behave in patients. The focus is on cardiovascular drugs and their potential interactions. Signals detected by the AI will be validated in laboratory models that simulate human drug metabolism, aiming to produce a reliable tool for clinicians to anticipate adverse effects and optimize co-prescribing. The initiative will also generate practical guidance for developers on integrating AI and real-world data with traditional trial evidence.
ARISE: AI to Support Regulators
The second project, funded with £1 million, is titled AI for Regulatory Insight, Safety, and Efficiency (ARISE). It pilots AI-assisted tools to support experts in scientific advice, clinical trial assessments, and licensing decisions, with final determinations remaining in human hands. The program seeks to demonstrate how regulators can responsibly deploy AI to enhance medicine safety, streamline development, and expedite patient access to new therapies.
Synthetic Data for Clinical Trials
The third initiative, receiving £259,250, will explore the use of synthetic patient data to bolster clinical trials in cancer, inflammatory bowel disease, and rare paediatric seizure conditions. Prior work suggests synthetic data can strengthen evidence in trials involving rare or underrepresented populations. The project includes a regulatory sandbox to help translate synthetic data approaches into policy and practice, promoting regulatory understanding and adoption.
Leadership Commentary and Vision
MHRA Chief Executive Lawrence Tallon emphasized the need for safety systems to match rising patient complexity and polypharmacy. He highlighted that integrating new tools and real-world health data can protect patients while speeding access to effective treatments. Tallon noted government support enables international leadership and demonstrated a path to more consistent, efficient regulation across the lifecycle, from early advice to licensing.
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