MHRA launches AI sandbox to accelerate medicines development and improve safety

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a first-of-its-kind regulatory sandbox designed to test how artificial intelligence can accelerate medicines development, improve patient safety, and reduce reliance on animal testing. Announced by Science Minister Lord Vallance at London Tech Week, the initiative provides a controlled environment for companies and researchers to explore AI tools that predict how medicines behave in the human body. The sandbox is funded by the UK Government’s Regulatory Innovation Office (RIO) and will test up to five AI-driven approaches in the first phase.

The BioIndustry Association (BIA) strongly welcomes the initiative as a vital mechanism to de-risk drug development and maintain the UK's position at the forefront of life sciences innovation. Highlighting the value for the sector, Professor Chris Molloy, CEO of the BIA, said:

We welcome this timely and important step which will accelerate medicines R&D in the UK and globally. UK innovators are developing AI-driven technologies and UK biotechs will adopt them. AI models have the potential to derisk drug development and deliver them to patients faster. But they need to be taught, tested and proven in a rigorous, safe space – which this sandbox delivers. We look forward to enabling a continued dialogue between MHRA and our members nationwide.

Dr Manish Patel, CEO of Jiva AI and BIA AI Subcommittee Chair, said:

This is a welcome and timely step that could help the UK lead in the responsible adoption of AI in life sciences. For SMEs in particular, a clear regulatory sandbox creates a much-needed route to prove value faster, reduce uncertainty, and bring innovative ADMET tools closer to real-world use in drug development and safety assessment. It also sends a strong signal that the UK is serious about building a modern, science-led ecosystem where advanced AI can support better decisions, faster innovation, and ultimately improved patient outcomes.

Dr Michalis Papadakis, CEO & Co-Founder of Brainomix said:

At Brainomix, we have hands-on experience how AI can transform healthcare when innovation is combined with rigorous clinical validation, real-world evidence, and clear regulatory frameworks. We therefore welcome the MHRA's AI-for-ADMET sandbox initiative as an important step towards unlocking the potential of AI in drug development. AI-based ADMET approaches offer a transformative opportunity to drive prediction of drug safety and efficacy. This will address longstanding translational challenges, reduce reliance on animal testing, and accelerate the development of new treatments for patients.

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.

 

Science Minister Lord Vallance said: 

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.

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. 

MHRA Chief Executive Lawrence Tallon 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. 

By working directly with developers and researchers, we can help create the right environment for innovation to thrive and cement the UK’s position as a world leader in life sciences.

Professor Alastair Denniston, NHS Doctor and Chair of the National Commission into the Regulation of AI in Healthcare, said:

This sandbox is a valuable opportunity for the UK to develop a practical, trusted approach to assessing AI models that predict drug safety and pharmacokinetics: helping regulators, researchers, and innovators understand what good evidence looks like,