Annual accountability review minutes 2024 to 2025: 29 October 2025
Updated 15 April 2026
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Meeting attendees
- Minister Dr Zubir Ahmed MP, Parliamentary Under Secretary of State for Health Innovation and Safety, Department of Health and Social Care (DHSC)
- Private Secretary, DHSC
- David Simmons, Interim Medicines Director, and Medicines and Healthcare products Regulatory Agency (MHRA) Senior Departmental Sponsor, DHSC
- Senior Policy Adviser MHRA Sponsorship, DHSC
- Lawrence Tallon, CEO, MHRA
- Professor Anthony Harnden, Chair, MHRA
- Dr Ed Middleton, Interim Director of Strategy, MHRA
Opening remarks
Minister Ahmed opened the meeting by welcoming attendees and invited Mr Tallon to provide an update on MHRA’s performance for 2024 to 2025.
The agency’s performance and strategic development in 2024 to 2025
Mr Tallon set out significant performance improvements that the agency achieved over the last year. MHRA has been through a difficult period, due to additional pressures placed on the agency through EU Exit and the COVID-19 pandemic, but the agency is now meeting all statutory targets including on timeliness of clinical trials authorisations and medicines licence approvals.
MHRA enforcement and safety work
Mr Tallon set out the important role the agency has in the enforcement and removal of fake and dangerous counterfeit medicines. He cited the success of Operation Subaru and the recent dismantling of a major illicit manufacturing facility which had been making and distributing unlicensed weight-loss jabs in Northampton.
Minister Ahmed congratulated MHRA on these successes and offered his support to this important work.
Mr Tallon and Professor Harnden set out plans to expand the safety and surveillance (Yellow Card) scheme to bring it into the ‘digital age’.
Minister Ahmed requested a separate meeting to learn more about the agency’s work around patient safety.
Objectives and priorities for 2025 to 2026
Mr Tallon stated that he wanted MHRA to have a forward-looking and expansive innovation agenda and referenced several projects the agency is progressing, including:
- Innovative Licencing and Access Pathway (ILAP)
- AI Airlock (regulatory sandbox of AI as a Medical Device (AIaMD))
Mr Tallon, Professor Harnden and Dr Middleton set out their plans to increase recognition of MHRA as a global standards and reference regulator.
Minister Ahmed agreed with these aspirations and offered his assistance in discussions around international co-operation.
Regulatory action plan progress
Mr Tallon set out aspirations for MHRA to have a more co-operative relationship with industry, academia and peer regulatory agencies.
To that end, Mr Tallon outlined progress being made in its partnership with the National Institute of Health and Care Excellence (NICE) in bringing marketing authorisation and reimbursement decisions into alignment. This will ultimately accelerate reimbursement decision timelines and allow patients access to medicines more quickly. It is hoped this will begin from 1 April 2026.
Financial performance 2024 to 2025
Mr Tallon stated that MHRA’s finances were in a good position, and he wished to expand the quality and volume of fee-generating activities the agency undertook.
Mr Tallon set out concerns with the RegulatoryConnect IT programme being developed by the agency.
Minister Ahmed noted the concerns raised and would respond formally to the advice he had received on the topic.
MHRA personnel and MHRA as a UK-wide regulator
Professor Harnden summarised recent work to ensure better representation outside of London and in the devolved nations across MHRA’s workstreams, including:
- board meetings held in locations outside of London
- opening a digital hub in Leeds in summer 2025
- plans for an enhanced MHRA presence across the UK nations
Minister Ahmed was supportive of MHRA’s plans.
Access to data
Dr Middleton raised the challenges faced by the agency in accessing data to support many of the agency’s core statutory activities, such as safety and surveillance.
Minister Ahmed agreed it was in the best interest of the agency to have timely and efficient access to the data it needs and offered his support.
Closing remarks
Minister Ahmed thanked attendees for their time, and congratulated MHRA on the good work they had done so far under new leadership.