MHRA launches AI sandbox to accelerate medicines development and improve safety

The UK will launch a first-of-its-kind initiative to test how artificial intelligence (AI) can help make medicines safer for patients  as announced by the Science Minister Lord Vallance during London Tech Week today (9 June 2026). 

The programme will explore how AI can improve the assessment of accuracy and safety, better predict risks, and detect effects that existing approaches may not capture.  

Adverse drug reactions send around 250,000 people to hospital in the UK every year, costing the NHS over £2 billion annually. Around 90% of drugs fail during development, in part because existing methods cannot always predict how medicines will behave in people. Promising treatments may not progress due to uncertainty in early safety testing.  

The Medicines and Healthcare products Regulatory Agency (MHRA) will establish a new regulatory sandbox, giving companies and researchers a controlled testing environment to work with regulators to explore how AI tools could be used to better understand medicines safety and predict potential side effects. 

Supported by funding from the UK Government's Regulatory Innovation Office, the sandbox will allow innovators to test AI tools that have the potential to predict how medicines behave in the body, including how they are absorbed, processed and whether they may cause harm. 

The programme will also explore how better use of clinical data can improve understanding of how medicines work across different groups, including those often underrepresented in studies such as children, older people and people from diverse backgrounds. 

The MHRA will use this work to understand how reliable these tools are and whether they can be used to support decisions about the safety of new medicines. By building a stronger evidence base and setting clear expectations for their safe use, this will give companies confidence to invest in innovation in the UK.  

It forms part of a wider effort to modernise medicines development, including the use of advanced modelling and synthetic data to improve how safety and effectiveness are assessed.  

This sandbox will support delivery of the Government's AI for Science Mission One to develop new treatments faster, and reinforces the UK's plans to drive alternatives to animal testing announced last November. This also supports the 10 Year Health Plan ambition for the UK to have the world's most AI-enabled healthcare system, helping patients benefit from faster access to safe, effective and innovative treatments. 

Up to five AI-driven approaches will be tested in the first phase. The MHRA will begin working with industry and academic partners from summer 2026 to shape how the sandbox operates. 

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, and supporting responsible innovation that accelerates the development of new medicines that will benefit patients.  

Professor Chris Molloy, CEO of the BioIndustry Association (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. 

Dan O'Connor, Executive Director of Regulatory policy at the ABPI, said:  

We welcome the growing focus on AI model development as an important step towards more predictive and efficient medicines development. This sandbox could be a step towards the safe harbour' that ABPI has called for, creating the trusted environment industry needs to develop and adopt regulatory-compliant AI models in medicines development. 

To succeed, this work will need meaningful industry engagement and should align closely with the work of the CERSIs to help build a coherent, trusted framework for innovation and regulatory adoption. We look forward to being part of the discussions to move this forward. 

Notes to editors 

• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work an are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. 

• The MHRA is an executive agency of the Department of Health and Social Care. 

• For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651. 

• A sandbox is a regulator-monitored virtual area for developers to generate robust evidence for their innovation. 

• The Regulatory Innovation Office has focused on 4 fast-growing areas of technology since it was established: engineering biology, space, artificial intelligence and digital in healthcare, and drones and other autonomous technology.