MHRA Report: Protecting UK Public Health With Record Success

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the UK Government’s Department of Health and Social Care responsible for ensuring that medicines and medical devices work as intended and are acceptably safe. 

Its 2025–26 Annual Report showcases the breadth of the agency’s impact in protecting public health and supporting the UK’s life sciences sector, from authorising hundreds of medicines and removing a record number of illegally traded products from circulation to pioneering new approaches to AI regulation. 

“This year’s Annual Report shows the MHRA delivering faster, more consistently and with even greater impact for patients, the NHS and innovators,” says Lawrence Tallon, CEO of the MHRA.

“From approving new medicines and supporting clinical research to disrupting criminal supply chains, our focus remains on protecting public health while embracing innovation.”  

Ensuring the safety of UK medicines 

As the UK’s principal regulator of medicines and medical devices, the MHRA achieved a record-breaking year in 2025–26 across several operational areas. 

It approved 921 medicinal products for use, including 39 new medicines, while assessing 100% of clinical trial applications and national medicines licence applications within target timelines.

Alongside its approvals, MHRA also removed a record 28.5 million doses of illegally traded medicines from circulation, with an estimated street value of £64.4m (US$86.6m).

This included the closure of the UK’s first known illegal factory producing unlicensed weight loss injections.

“The MHRA has… responded effectively to emerging risks, including the threat from illicit and unregulated products, while continuing to provide clear, science-based information to patients and the public,” writes Professor Anthony Harnden, Chair of the MHRA, in the 2025-26 Annual Report.

Integrating AI into the UK healthcare system

The MHRA also played a key role in advancing the safe integration of AI into the UK’s health infrastructure, supporting the ambitions of the NHS 10 Year Health Plan – the government’s strategy to build a health service fit for the future.  

Launched by the MHRA in September 2025, the National Commission into the Regulation of AI in Healthcare is developing recommendations for a future-ready regulatory framework for AI. 

Bringing together experts from healthcare, technology, academia and patient groups, it aims to support safe innovation, protect patients and strengthen the UK's position as a global leader in AI-enabled healthcare and life sciences. 

During 2025–26, the MHRA also expanded its AI Airlock initiative, the UK’s first regulatory sandbox for AI as a medical device.

The programme enables innovators, regulators and the NHS to test emerging AI safely, informing practical regulatory development for technologies such as large language models, while positioning the UK as a global leader in AI-enabled healthcare. 

Operating with sustainability front-of-mind

MHRA’s Annual Report also includes a dedicated section outlining its sustainable performance and targets.

Key sustainability highlights from the report include organisational carbon emissions falling 36.7% below the 2017 baseline, 12% of electricity at the MHRA Science Campus being generated by solar panels and emissions at its Canary Wharf offices decreasing by 78.3%. 

MHRA, in alignment with the Department of Health and Social Care’s emission reduction plans, aims to achieve net zero emissions across its building estate by 2030. 

Future strategy

Looking ahead, MHRA plans to implement new Clinical Trials Regulations, including a 14-day first assessment for phase 1 clinical trials, making it simpler and faster to run safe, high-quality clinical trials in the UK. 

The agency will also publish its new MHRA2030 Strategy, outlining how it will further strengthen patient safety, support innovation and enhance its development as a modern, science-led regulator.

The MHRA2030 Strategy, Lawrence says, “will act as a clear blueprint for the next phase of our development, setting out how we will build on restored performance to strengthen patient safety, support innovation and enhance our role as a modern, science-led regulator, ensuring patients benefit more quickly without compromising safety.”