MHRA launches AI regulatory sandbox to advance medicines development and safety assessment

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced a new regulatory sandbox that will evaluate how AI can support medicines development and safety assessment, while helping establish an evidence base for its future use in regulatory decision-making.

The Baseline

• The MHRA has launched a regulatory sandbox to evaluate the use of AI in medicines development and safety assessment.
• The initiative will test AI models in a controlled environment to build an evidence base for future regulatory decision-making.
• The program forms part of wider UK efforts to modernize medicines development through AI-enabled technologies.

Announced by the UK’s Science Minister, Lord Patrick Vallance, during London Tech Week on June 9, 2026, the initiative will provide a controlled environment in which regulators, researchers, and developers can test AI models designed to support the assessment of medicines.

The program will explore how AI can predict how medicines behave in the body, including how they are absorbed, processed, and whether they may cause harmful effects. It will also examine whether clinical data can be used more effectively to understand medicine performance across different patient populations, including children, older people, and people from diverse backgrounds, who are often underrepresented in research.

The initiative responds to longstanding challenges in medicines development. According to the UK Government, adverse drug reactions result in around 250,000 hospital admissions each year and cost the NHS more than £2 billion annually, while approximately 90% of medicines fail during development because existing methods cannot always predict how treatments will behave in people. The government also notes that uncertainty during early safety testing may prevent promising medicines from progressing.

Commenting on the announcement, Lord Vallance stated:

“Too many promising medicines fail late in development or never reach patients because the evidence needed to support them is difficult and slow to generate.”

He added that “by leveraging our strengths in life sciences, AI and pro-innovation regulation, this sandbox will help make the UK one of the best places in the world to develop the next generation of medicines safely.”

Supported by funding from the UK Government's Regulatory Innovation Office, the sandbox forms part of wider efforts to modernize medicines development through advanced modeling, synthetic data, and AI-enabled technologies. The first phase will evaluate up to five AI-driven approaches, with the MHRA expected to begin working with industry and academic partners from summer 2026. The agency will use the findings to assess the reliability of these technologies and their potential role in supporting medicines safety assessment and regulatory decision-making.

MHRA Chief Executive Lawrence Tallon said AI technologies could help regulators “understand medicines better, generate stronger evidence on their safety, and accelerate the development of innovative treatments, especially in areas of unmet need.” He added that:

“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 sandbox also aligns with broader government efforts to modernize medicines development, reduce reliance on animal testing, and expand the use of AI across healthcare. Welcoming the initiative, Professor Chris Molloy, Chief Executive of the BioIndustry Association, said AI models “have the potential to derisk drug development and deliver them to patients faster,” but stressed that they “need to be taught, tested and proven in a rigorous, safe space – which this sandbox delivers.”