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.
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:
- 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.
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.