The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of a first-of-its-kind regulatory sandbox designed to explore how artificial intelligence (AI) can support safer medicines development. Announced during London Tech Week on 9 June 2026, the initiative aims to investigate how AI tools could improve safety assessments, predict risks more effectively, and identify effects that existing approaches may not detect.

The programme will also examine how AI may contribute to reducing reliance on animal testing and accelerating access to innovative treatments.

Addressing Challenges in Medicines Development

According to the MHRA, adverse drug reactions lead to approximately 250,000 hospital admissions in the UK each year and cost the National Health Service (NHS) more than £2 billion annually.

The Agency also noted that around 90% of medicines fail during development, partly because existing methods cannot always accurately predict how medicines will behave in humans. As a result, promising therapies may not progress due to uncertainty during early safety testing.

A Regulatory Sandbox for AI Innovation

The MHRA will establish a regulatory "sandbox" that provides companies and researchers with a controlled environment to work alongside regulators in exploring the use of AI tools in medicines development.

Within this setting, innovators will be able to test AI technologies designed 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 participants to evaluate AI tools capable of predicting how medicines behave in the body, including:

• how medicines are absorbed;
• how they are processed; and
• whether they may cause harm.

Exploring the Use of Clinical Data

The programme will also investigate how improved use of clinical data may enhance understanding of how medicines perform across different populations.

The MHRA highlighted that this includes groups that are often underrepresented in studies, such as:

• Children
• Older people
• People from diverse backgrounds.

The Agency intends to use the findings to assess the reliability of these AI tools and determine whether they can support decision-making related to the safety of new medicines.

By strengthening the evidence base and establishing clear expectations for safe use, the MHRA stated that the initiative could provide companies with greater confidence to invest in innovation within the UK.

Supporting Wider Modernisation Efforts

The sandbox forms part of broader efforts to modernise medicines development.

According to the MHRA, these efforts include the use of advanced modelling and synthetic data to improve how safety and effectiveness are assessed.

The initiative also supports:

• The Government's AI for Science Mission One, aimed at developing new treatments more rapidly;
• UK plans to promote alternatives to animal testing announced in November 2025; and
• The ambitions outlined in the 10 Year Health Plan for the UK to become the world's most AI-enabled healthcare system.

Initial Phase and Industry Collaboration

During the first phase of the programme, up to five AI-driven approaches will be tested.

The MHRA plans to begin working with industry and academic partners from summer 2026 to shape the operation of the sandbox.

Statements from Key Stakeholders

Health Innovation Minister Preet Gill

Preet Gill stated:

"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."

She added that providing innovators with a safe environment to test these tools alongside regulators would help build the evidence needed to deliver safer and more effective treatments more quickly, reduce reliance on animal testing, and create a smarter medicines development process.

Science Minister Lord Vallance

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."

He stated that the sandbox would help position the UK as one of the best places in the world to develop the next generation of medicines safely by leveraging strengths in life sciences, AI and pro-innovation regulation.

MHRA Chief Executive Lawrence Tallon

Lawrence Tallon commented that advances in AI and biomedical science present opportunities to deliver benefits for patients.

He noted that these technologies could improve understanding of medicines, generate stronger evidence relating to safety, and accelerate the development of innovative treatments, particularly in areas of unmet need.

He also stated that this could provide patients with greater confidence that medicines are supported by evidence reflecting the diversity of people they are intended to treat.

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

Professor Alastair Denniston described the sandbox as:

"a valuable opportunity for the UK to develop a practical, trusted approach to assessing AI models that predict drug safety and pharmacokinetics."

He added that it could support regulators, researchers and innovators in understanding what constitutes good evidence while encouraging responsible innovation.

CEO of the BioIndustry Association (BIA) Professor Chris Molloy

Professor Chris Molloy welcomed the initiative, describing it as an important step in accelerating medicines research and development in the UK and globally.

He noted that AI models have the potential to reduce risks in drug development and help deliver treatments to patients more quickly, provided they are developed and tested in a rigorous and safe environment.

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

Dan O'Connor stated that the sandbox could represent progress toward the "safe harbour" environment previously advocated by the Association of the British Pharmaceutical Industry (ABPI).

He emphasised the importance of meaningful industry engagement and alignment with existing initiatives to support trusted regulatory adoption of AI models in medicines development.

Notes to Editors

The MHRA is responsible for regulating medicines and medical devices in the UK by ensuring that they work and are acceptably safe. The Agency states that its work is underpinned by robust and fact-based judgements to ensure that benefits justify risks.

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

The source defines a sandbox as a regulator-monitored virtual area that enables developers to generate robust evidence for their innovations.

The Regulatory Innovation Office has focused on four rapidly growing areas of technology:

• Engineering biology
• Space
• Artificial intelligence and digital healthcare
• Drones and other autonomous technologies.

For more information: MHRA launches AI sandbox to accelerate medicines development and improve safety

Implications for Drug Safety and Pharmacovigilance

As regulatory authorities explore new technologies to strengthen medicines safety assessment, robust pharmacovigilance systems remain essential throughout the product lifecycle.

At Baupharma, our Pharmacovigilance Services support organisations in maintaining compliance while strengthening ongoing safety monitoring through activities such as adverse event management, signal detection, aggregate reporting, and risk management.