The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2025–26 Annual Report and Accounts highlighting a year of strong and consistent delivery as set out in the agency’s first Results and Forecast report earlier this year.
The annual report, which is being laid before Parliament, demonstrates how the MHRA has maintained a consistently high level of performance throughout the year, delivering for patients, the public and industry while building a strong foundation for future innovation and growth.
It highlights the breadth of the agency’s impact in protecting public health and supporting the UK’s life sciences sector, including authorising hundreds of medicines, removing a record number of illegally traded products from circulation, and pioneering new approaches to AI regulation.
Lawrence Tallon, MHRA Chief Executive, said
“This year’s Annual Report shows the MHRA delivering faster, more consistently and with even greater impact for patients, the NHS and innovators. From approving new medicines and supporting clinical research to disrupting criminal supply chains, our focus remains on protecting public health while embracing innovation.”
The MHRA further strengthened its international standing during the year. The agency was designated a World Health Organization (WHO) Listed Authority, recognising the quality and robustness of the UK regulatory system, while continuing to play a leading role in international regulatory collaboration through initiatives including the ACCESS consortium.
Highlights of the MHRA’s work in 2025–26 include
- Approving 921 medicinal products for use, including 39 new medicines, while assessing 100% of clinical trial applications and national medicines licence applications within target timelines.
- Removing a record 28.5 million doses of illegally traded medicines from circulation, with an estimated street value of £64.4 million, including the shutdown of the UK’s first known illegal factory producing unlicensed weight loss injections.
- Playing a leading role in shaping the future regulation of AI in healthcare, with the launch of the National Commission into the Regulation of AI in Healthcare bringing together global AI leaders, clinicians and regulators to advise the MHRA on the development of a new regulatory framework.
- Proposing a new Rare Disease Therapies Regulatory Framework to support earlier, more frequent, and iterative engagement with developers, providing structured regulatory flexibility where conventional approaches are not feasible. Jointly launching the MHRA-NICE aligned regulatory pathway, which aims to accelerate patient access to some medicines by up to six months.
- Securing £7.5 million in new research grant funding to advance regulatory science and support innovation in medicines and medical devices.
- Supporting public health research and regulatory decision-making through the Clinical Practice Research Datalink (CPRD), using anonymised UK primary care data to generate real-world evidence.
- Supplying more than 154,000 biological reference materials globally, supporting the quality, safety and effectiveness of medicines and vaccines worldwide.
Looking ahead to 2026–27, the MHRA will implement new Clinical Trials Regulations, including a 14-day first assessment for phase 1 clinical trials, making it easier and faster to run safe, high-quality clinical trials in the UK. The agency will publish its new MHRA2030 Strategy, setting out how it will build on sustained performance to strengthen patient safety, support innovation and enhance its development as a modern, science-led regulator.
This year’s Annual Report and Accounts builds on the agency’s Results and Forecast 2025/26; 2026/27 report, published earlier in the year, which set out the MHRA’s key achievements to date and its priorities for the year ahead. Further information on the agency’s performance and future plans can be found in that report, alongside today’s publication.
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 and 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.
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