MHRA sets out plans for AI and medicines regulation

Published on 14 October 2026, the MHRA’s five-year strategy describes how it plans to modernise regulation amid rapid advances in science, technology and global healthcare.[1][2] The regulator says its mission is “health and prosperity for all, through scientific excellence.”[2] By 2030, it aims to support faster patient access to safe, effective treatments and increase its data connectivity and global influence.[1] The MHRA also says its wider aims include making the NHS the world’s most AI-enabled health system and strengthening the UK’s position as a global life sciences leader.[3]

The MHRA plans to analyse real-world data with AI to identify potential safety issues earlier.[1] It intends to work with the Health Data Research Service on real-time surveillance, with the aim of spotting safety signals sooner and collecting data on investigational medicines.[1] The agency also plans to make adverse-event reporting through its Yellow Card system simpler and quicker for patients and healthcare professionals.[1] It says it will move toward continuous, real-time safety assurance using data, analytics and AI to identify risks earlier and respond faster.[2] These are plans in the strategy, not evidence that the proposed systems are already operating.

The MHRA plans to publish an AI Medicines Development Action Plan in 2027, setting out how AI will be used to transform medicines development.[1] It also plans an AI-enabled Clinical Trial Protocol Checker to give sponsors regulatory certainty and support faster, higher-quality trial applications.[1] A proposed Centre for AI and Digital Health would clarify regulatory expectations for developers of digital and AI-driven medical devices and medicines.[1] Separately, the agency plans a modern, adaptive regulatory framework for AI as a medical device.[1] Pharmaphorum reports that the current regulatory framework for healthcare AIs was found to be inadequate.[3]

The strategy proposes a higher-value service option that would reduce the time for scientific advice to medicine and medical-product developers from 90 days to 45 days.[1] The MHRA also plans to halve the initial assessment target for qualifying Phase 1 clinical trials to 14 days.[1] Other plans include increasing diversity in clinical studies, launching a Women’s Health Plan this year and refreshing its patient and public involvement plan this year.[1] The agency also plans to shift toward human-relevant methods such as organoids, offer targeted vouchers to UK start-ups and smaller companies, and create more flexible routes for rare-disease therapies.[1]