Lawrence Tallon, chief executive at the Medicines and Healthcare products Regulatory Agency (Credit: MHRA)
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to launch a new AI regulatory sandbox aimed at improving medicines safety and accelerating the development of new treatments.
The initiative, unveiled by Science Minister Lord Vallance on 9 June 2026, will provide companies and researchers with a controlled environment to test AI tools designed to predict how medicines may perform in people and identify potential safety risks earlier in the development process.
Through the sandbox, the MHRA will work with industry and academic partners to assess whether AI can improve medicines safety assessment and identify risks that traditional methods may miss.
Unlike the AI Airlock programme, which focuses on AI medical devices, the new sandbox will support the testing of AI tools used in medicines development and safety assessment.
Up to five AI technologies will be tested during the first phase of the programme, with work due to begin in summer 2026.
Lawrence Tallon, chief executive at the MHRA, said: “We’re seeing extraordinary advances in AI and biomedical science. The opportunity now is to harness them to deliver real benefits for patients.
“These technologies could help us understand medicines better, generate stronger evidence on their safety, and accelerate the development of innovative treatments, especially in areas of unmet need.
“For patients, that means greater confidence that the medicines they rely on are supported by the best available science, with evidence that better reflects the diverse range of people they are intended to treat.”
The programme is intended to address longstanding challenges in medicines development, where around 90% of drug candidates fail during development, often because existing methods cannot accurately predict how treatments will perform in people.
Backed by funding from the government’s Regulatory Innovation Office, the initiative comes as adverse drug reactions continue to place a significant burden on the NHS, contributing to around 250,000 hospital admissions annually and costing more than £2 billion each year.
The sandbox forms part of the government’s wider AI for Science programme and supports efforts to modernise medicines development through advanced modelling, synthetic data and alternatives to animal testing.
Preet Gill, health innovation minister, said: “By giving innovators a safe space to test these tools alongside regulators, we can build the evidence base needed to get safer, more effective treatments to patients faster.
“That means fewer adverse reactions, less reliance on animal testing, and a smarter, more efficient medicines development process.”
In April 2026, the MHRA secured a funding increase to expand its AI Airlock programme. Following a successful second phase, the Department of Health and Social Care allocated the programme £1.2 million per year for the next three years.
The funding will enable the programme to continue beyond annual budget cycles and support longer-term testing models, helping to create a more sustainable regulatory pathway for future AI medical technologies.