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Welcome to your April 2025 edition of MHRA News.
The essential industry newsletter where we update you on our most recent activities.
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Lawrence Tallon began his role as Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency (MHRA) on 1 April 2025.
Lawrence brings a strong focus on patient safety, innovation and partnership working, which have been central to his previous roles including as Deputy Chief Executive of Guy’s and St Thomas’ NHS Foundation Trust since March 2020.
Lawrence said: “I am delighted to be joining the MHRA, which plays a vital role in ensuring people across the UK and the NHS have access to safe and effective medicines and medical devices.
“My priorities are patient safety, improving patient access to new medicines and medical devices through risk-proportionate regulation, innovation and growth, and building partnerships in the UK and internationally.”
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 The March performance data from the MHRA has been published: https://www.gov.uk/government/publications/mhra-performance-data
We are committed to delivering predictable, optimised, and sustainable services, across all our functions. We have met our ambitious targets in delivering efficient performance and clearing backlogs in statutory functions, and we are continuing to embed new ways of working to maximise productivity, in ways that put patients and public health outcomes first.
We can confirm that from 31 March 2025, we have cleared all backlogs relating to statutory functions (licence applications for innovative and established medicines, variations to licences, and manufacturing and distribution authorisations).
100% of clinical trials and investigations applications continue to be handled within statutory timescales. Combined Review approval time with the Health Research Authority is now at 60 days or less for all trials, with an average time for Combined Review determination (including questions raised) of just 40 days in March.
On 31 March 2025, we cleared all backlogs related to licence applications for innovative and established medicines. All new licensing applications submitted from September 2024 are being delivered within statutory timescales. We also completed 100% of assessments of International Recognition Procedure (IRP) applications within statutory timeframes in March.
On 31 March 2025, we cleared all backlogs relating to variations to licences and to manufacturing and distribution authorisations and have made significant progress to return to these areas to statutory timelines
We continue our review, rebuild, and renewal of our scientific advice service to improve performance. More resources are now available to help clear scientific advice requests. We expect early signs of positive impact to be reported in our data for April.
 A 12-month roll-out began in April for the biggest regulatory shake up of clinical trials in 20 years.
New regulations for running clinical trials in the UK have now been signed into law. A 12-month roll-out began on the 11 April to deliver the most significant update to UK clinical trials regulation in two decades – with the aim of strengthening patient safety, accelerating approvals, enabling innovation and helping more people benefit from taking part in vital research.
Additionally, new analysis of the current clinical trial landscape in the UK shows clear opportunities to shape the future of medical research and patient care.
The first-ever analysis of the UK clinical trial landscape by the Medicines and Healthcare products Regulatory Agency (MHRA) and the University of Liverpool reveals the UK is a global leader in clinical research – and sets out key opportunities to deliver even more life-changing treatments for patients.
Published in the British Journal of Clinical Pharmacology, the report offers the most detailed picture yet of the UK’s clinical trials landscape. It finds strong innovation – but also a concentration of research in certain disease areas, and opportunities for increased representation of certain patient groups.
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This month we approved trastuzumab deruxtecan (Enhertu) to treat people with solid tumours that have mutations in human epidermal growth factor 2 (known as HER2 positive cancers) that have spread to other parts of the body (metastatic disease) or cannot be removed by surgery (unresectable), and who have no alternative treatment options.
This approval is an extension to the indication (use) of the medicine, which has previously been approved for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancers, who have received two or more prior anti-HER2-based regimens for non-small cell lung cancer with an activating HER2 mutation and HER2-postive gastric cancer.
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We’ve published a blog, MedTech regulatory reform and the importance of partnerships, which reflects on the collaboration across government, the NHS, academia and industry critical to the MHRA as we shape regulation that supports innovation and patient safety.
In the blog, deputy director of innovative devices Rob Reid, gives updates on the UK’s new Centres of Excellence for Regulatory Science and Innovation (CERSIs) and the MHRA’s AI Airlock pilot. He also gives insight from the International Medical Device Regulators Forum and progress on post-market surveillance and routes to market regulatory reforms.
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Registrations are now open for our 15 May webinar to help anyone developing, procuring or using digital mental health technologies to navigate medical device regulations.
Digital mental health technologies such as apps, AI-powered assessments and virtual reality therapies which diagnose, prevent, or treat conditions using complex software must meet medical device standards to ensure they are effective and acceptably safe, just like any other medical device.
Our 15 May webinar will provide a deep dive into our guidance for these technologies, providing information about how medical device regulations apply to software, which products are regulated, how they are assessed, and what evidence is required.
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For any comments and feedback on this newsletter, please email: info@mhra.gov.uk.
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