The Medicines and Healthcare products Regulatory Agency (MHRA) has met or exceeded all statutory targets to increase access to medicines and medical devices for UK patients.
New data from the MHRA Results and Forecast report shows that the MHRA delivered against every statutory commitment, meeting all key performance indicators with excellent on-time performance across licensing, clinical trials, and safety decisions.
The MHRA has been working to strengthen its position as a world-leading medicines regulator by striking new global partnerships and advancing pioneering work in clinical trials reform, AI regulation, and rare disease therapeutics pathways.
The new data shows that the MHRA has strengthened patient and public safety by tackling health misinformation, introducing stronger post- market surveillance rules for medical devices, removing nearly 28 million unauthorised medicine doses and modernising safety monitoring through enhanced vigilance systems.
Over the year, the agency strengthened collaboration across the UK and globally, including the MHRA–National Institute for Health and Care Excellence’s (NICE) aligned pathway to accelerate patient access, a new UK–Singapore Innovation Corridor, inaugural membership of the HealthAI network and collaboration with the US Food and Drug Administration (FDA) on medicinal device regulation as part of the wider US-UK pharmaceutical partnership.
The agency also ended the year in financial surplus and increased staff engagement, with record participation in the staff survey, and a significant improvement in the Engagement Score.
Lawrence Tallon, MHRA Chief Executive, said: “We have a regulatory environment that’s scientifically rigorous, agile and has patients at its heart. Whether it’s enabling access to the next generation of medicines and health technologies or protecting patients from harm, our success is measured not just in frameworks and timelines, but in improved lives.
“With every performance target met, a strong financial position and more innovative medicines reaching patients, this is high quality regulation in practice. It is testament to the dedication of our committed and expert workforce and the strong partnerships we have with the wider UK and global health and life sciences system.”
Health Minister Dr Zubir Ahmed, said: “This past year has shown what a modern regulator looks like: patients first, pace where it matters, and standards that never slip. The MHRA has made tangible progress on this Government’s ambitions for the NHS, public health, and the Life Sciences Sector Plan. The direction of travel is clear. With the MHRA operating as a high-performance regulator, the UK is positioned as a global destination for life sciences that is open to innovation, serious about safety, and credible on the world stage.”