The MHRA will create an AI "sandbox" to let developers, academics and regulators test AI methods that could improve predictions of drug safety and reduce adverse reactions. Backed by the Government’s Regulatory Innovation Office, the initial phase will assess up to five AI-driven approaches and will involve industry and academic partners from summer 2026. The programme aims to improve precision, include underrepresented patient groups, and inform how regulators judge the reliability of AI tools in medicines decisions.
MHRA Launches AI Sandbox to Speed Safer, More Inclusive Drug Development
The MHRA intends to use findings from the sandbox to evaluate the reliability of AI tools for new medicines’ safety. Credit: Gorodenkoff / Shutterstock.com.(Gorodenkoff / Shutterstock.com.)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new AI "sandbox" designed to accelerate drug development and strengthen patient safety by enabling innovators, academics and regulators to test AI-driven approaches in a controlled environment.
What the Sandbox Will Do
The programme will explore how artificial intelligence can sharpen assessments of drug precision and safety, improve risk forecasting, and surface adverse effects that conventional methods may miss. It will allow teams to test AI systems and simulate how medicines behave inside the body to better predict absorption, metabolism and potential harms.
Scope, Funding and Timeline
Funding for the initiative comes from the UK Government’s Regulatory Innovation Office. The initial phase is expected to evaluate up to five AI-driven approaches. The MHRA plans to work with industry partners and academic groups from summer 2026 to define the sandbox’s operational design, participation rules and evaluation criteria.
Why It Matters
Adverse drug reactions lead to around 250,000 hospital admissions each year in the UK and cost the National Health Service (NHS) more than £2bn ($2.67bn) annually. At the same time, roughly 90% of candidate medicines fail during development, in part because existing methods cannot always predict how treatments will behave in patients. The sandbox aims to reduce these gaps by validating AI tools that improve predictions and broaden the evidence base for safety decisions.
Inclusion and Modernisation
A key objective is to test whether AI can make better use of clinical data from groups that are often underrepresented in trials, such as children, older adults and people from diverse backgrounds. The sandbox is part of wider efforts to modernise medicine development through advanced modelling techniques and the use of synthetic data.
UK Health Innovation Minister Preet Gill said: "The AI revolution is here, and we want our NHS staff to be the first in the queue, armed with rigorously tested clinical AI tools. 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. Through our 10 Year Health Plan, we are driving the NHS to be the most AI-enabled healthcare system in the world."
The MHRA intends to use lessons from the sandbox to assess the reliability of AI tools when making regulatory decisions about new medicines. In March 2026, following reforms to the UK's medicine regulation process, the MHRA and the National Institute for Health and Care Excellence began making concurrent decisions on new drugs, reflecting closer alignment between approval and assessment pathways.
By clarifying evidence requirements and safe-use expectations for clinical AI, regulators hope the sandbox will encourage investment and innovation in the UK life sciences sector while improving patient outcomes.
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