The Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2024–25 Annual Report and Accounts, and accompanying Impact Report, demonstrating how we have enhanced patient safety across the UK, restored our performance to ensure we are meeting regulatory timelines, and sharing our success in enabling access to life-changing medical products.

As an executive agency of the Department of Health and Social Care, the MHRA plays a critical role in protecting public health while supporting the UK’s £100 billion life sciences sector. Over the past year, the agency has significantly improved its core operations by enhancing safety systems, clearing licensing backlogs, and helping bring safe innovative treatments and technologies to patients faster.

Highlights of the MHRA’s work in 2024–25 include:

• Clearing all statutory backlogs by March 2025 and consistently meeting statutory targets for clinical trials.
• Approving more than 2,000 licences for medicines, including 54 new medicines, such as treatments for Alzheimer’s, rare diseases, and cancer.
• Assessing over 5,000 clinical trial applications and launching the UK’s most significant clinical trial regulatory reform in over two decades.
• Supporting patient safety through the assessment of over 100,000 adverse drug reaction reports and blocking over 1.5 million unregulated online listings.
• Piloting a world-first AI Airlock to safely develop artificial intelligence in medical devices.
• Providing over 127,000 units of biological standards worldwide and launching new World Health Organisation-endorsed standards to strengthen global pandemic preparedness.

The reports also reflect the MHRA’s strengthened focus on patient and public engagement, environmental sustainability, and global regulatory collaboration, with over £7 million in research grants supporting cutting-edge regulatory science.

The reports also highlight the MHRA’s focus on strengthening internal capability and real-world evidence. Through the Clinical Practice Research Datalink (CPRD), the agency continues to support public health research with anonymised data from UK GP practices.

Internally, the MHRA has enhanced its digital infrastructure, improved cyber resilience, and modernised customer services, while investing in its people through graduate schemes, apprenticeships, and strong governance.

View the MHRA Annual Report and Accounts 2024–25 and MHRA Impact Report 2024–25.

For media enquiries, please contact: newscentre@mhra.gov.uk or call 020 3080 7651.