The Medicines and Healthcare products Regulatory Agency will launch an AI medicines sandbox after Science Minister Lord Vallance announced the programme at London Tech Week on 9 June 2026, with up to five AI-driven approaches to be tested in its first phase.
The programme will give companies and researchers a controlled environment to work with regulators on AI tools linked to medicines safety. It will begin with industry and academic partners from summer 2026.
The sandbox is supported by funding from the UK Government’s Regulatory Innovation Office. It will examine how AI could help predict how medicines behave in the body, including whether they may cause harm.
UK launches AI medicines sandbox
The MHRA will establish the sandbox as a regulator-monitored setting for testing AI approaches in medicines development. The announcement was made during London Tech Week, placing the programme within wider UK work on science, health innovation and regulation.
The initiative will focus on AI tools that may support decisions about the safety of new medicines. Developers will work with regulators while evidence is assessed against clear expectations for safe use.
- Lead body: the Medicines and Healthcare products Regulatory Agency will run the sandbox and assess how AI tools perform.
- Government support: the Regulatory Innovation Office is funding the programme as part of its work on fast-growing technologies.
- Initial scale: up to five AI-driven approaches will be tested in the first phase.
Programme aims to improve safety evidence
The programme will explore how AI can improve assessment of accuracy and safety, better predict risks, and detect effects that existing approaches may not capture. The MHRA said adverse drug reactions send around 250,000 people to hospital in the UK each year.
The agency also said around 90% of drugs fail during development, partly because existing methods cannot always predict how medicines will behave in people. The sandbox will examine whether AI tools can help generate stronger evidence earlier in the development process.
Medicines Safety And Development Indicators
| Indicator | Recent Movement | Context |
|---|---|---|
| Adverse drug reactions | Around 250,000 UK hospital admissions annually | The MHRA said these reactions cost the NHS over £2 billion each year. |
| Drug development failure | Around 90% of drugs fail during development | The agency linked this partly to limits in predicting how medicines behave in people. |
| First phase scope | Up to five AI-driven approaches | The MHRA said these approaches will be tested as the sandbox begins operating with partners. |
Support for innovation and patient safety
The sandbox is intended to give innovators a safe space to test tools alongside regulators. The MHRA said this will help build the evidence base needed to support decisions about new medicines.
By setting expectations for safe AI use, the programme is also intended to give companies more confidence to invest in innovation in the UK. The approach links medicines regulation with efforts to improve safety, development speed and patient outcomes.
Clinical data and underrepresented groups
The programme will explore how better use of clinical data can improve understanding of how medicines work across different groups. This includes groups often underrepresented in studies, such as children, older people and people from diverse backgrounds.
The MHRA said stronger evidence could help reflect the range of people medicines are intended to treat. The sandbox will assess whether AI tools can support that evidence while maintaining regulatory oversight.
- Patient groups: the programme will consider children, older people and people from diverse backgrounds.
- Evidence use: clinical data will be examined for its potential to improve understanding of medicine effects.
- Safety focus: AI tools will be assessed for reliability before they can support safety decisions.
Links to wider health and science policy
The sandbox forms part of wider efforts to explore how artificial intelligence can support medicines development and regulatory decision-making. The MHRA said the programme will help assess whether AI-generated evidence can be used reliably in areas such as drug safety, pharmacokinetics and treatment development.
Policy Links For The Sandbox
| Indicator | Recent Movement | Context |
|---|---|---|
| AI for Science Mission One | Sandbox aligned with faster treatment development | The government said the programme supports the mission’s work on new treatments. |
| Animal testing alternatives | Programme reinforces plans announced last November | The announcement links AI medicines development with reduced reliance on animal testing. |
| 10 Year Health Plan | Supports AI-enabled healthcare ambition | Ministers connected the sandbox to wider NHS plans for safe clinical AI adoption. |
First phase and industry involvement
The MHRA will begin working with industry and academic partners from summer 2026 to shape how the sandbox operates. The first phase will test up to five AI-driven approaches.
The approaches will examine AI tools that may predict how medicines are absorbed, processed and whether they may cause harm. The MHRA will use the work to understand reliability and whether these tools can support safety decisions.
Stakeholder Comments
Ministerial Comments
Lord Vallance, Science Minister 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.”
Lawrence Tallon, MHRA Chief Executive 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.”
What the sandbox means for regulation
The MHRA said a sandbox is a regulator-monitored virtual area where developers can generate robust evidence for their innovation. In this case, it will support testing of AI tools that may be used in medicines safety and development.
The agency regulates medicines and medical devices in the UK by assessing whether they work and are acceptably safe. Its work is based on fact-based judgements about whether benefits justify risks.
The MHRA AI medicines sandbox will test how artificial intelligence can support safer and faster medicines development under regulatory oversight. The first phase will involve up to five AI-driven approaches, with industry and academic partners engaged from summer 2026. The programme links medicines safety, patient evidence, life sciences innovation and government plans for wider healthcare AI use.
Sources: Medicines and Healthcare products Regulatory Agency, Science Minister Lord Vallance, Health Innovation Minister Preet Gill, MHRA Chief Executive Lawrence Tallon, Regulatory Innovation Office.
Prepared by Ivan Alexander Golden, Founder of THX News, an independent news organisation delivering timely insights from global official sources. Combines AI-analysed research with human-edited accuracy and context.
