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Welcome to your July 2025 edition of MHRA News.
The essential industry newsletter where we update you on our most recent activities.
To keep hearing from us with future editions, register here.
For a summary of the latest safety alerts for medicines and medical devices please refer to our latest MHRA Safety Roundup or subscribe to receive it to your inbox.
This is a significant moment for the MHRA. As part of our indispensable role in the Government’s 10-Year Health Plan and the Life Sciences Sector Plan, we are driving commitments to cut clinical trial timelines, improve market access in partnership with NICE, and enable the potential of AI as a medical device and in drug discovery. Working collaboratively across the life sciences sector, we are unlocking faster and still safe access to innovative medicines and technologies.
As we rise to meet this exciting opportunity for UK health services and life sciences, we are recruiting a new Chief Medical and Scientific Officer. This pivotal role is not only critical to our organisation, but also vital to the future of a vibrant health and life sciences ecosystem in the UK. We are seeking a dynamic, inclusive and visionary leader who shares our mission to improve people’s lives in the UK and on a global scale.
If you have the experience and commitment, and you would like the unique opportunity to make a lasting impact on UK public health and innovation, we want to hear from you. Please find out more about the role online. You can also listen to a recent podcast I have recorded on Unlocking Opportunities of the Healthcare Sector.
Warm regards,
Lawrence Tallon
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 We continue to report consistent performance against agreed key performance indicators in MHRA’s statutory functions: licence applications for innovative and established medicines, variations to licences, and manufacturing and distribution authorisations. Average timescales for statutory functions are reducing in most areas.
Our priority is to maintain performance to predictable and statutory timeframes, while delivering against our ambition to accelerate patient access to life-changing medicines and medical technologies. We will continue to publish monthly updates providing applicants with transparent information on expected timescales.
Our data for June 2025 show that 100% of clinical trials and investigations applications continue to be handled within statutory timescales. The latest data show an average time for Combined Review determination (including questions raised) of 41 days in May.
100% of national licence applications continue to be assessed within our statutory timescales of 210 days: with an average timescale of 166 days in June.
More resources are now available to help clear scientific advice requests and we expect further signs of positive impact to be reported in our data for future months. We will sustain this effort and by Autumn 2025, we will have restored performance in scientific advice to expected timescales, and will provide more information over the coming months as part of our wider work to further develop and enhance our scientific advice services.
In July 2025, the Government’s 10-Year Health Plan and Life Sciences Sector Plan set out a bold vision to transform the NHS and position the UK as the leading life sciences economy. Both plans place the MHRA at the centre of delivery, recognising our role in enabling faster access to novel therapies and positioning the UK as a global leader in life sciences.
The 10 Year Health Plan calls on the MHRA to accelerate regulatory pathways for AI-enabled devices and personalised medicines, and to align with NICE for faster evaluations. The Life Sciences Sector Plan builds on this by committing to remove barriers to innovation. It highlights our progress in restoring regulatory performance and sets out new commitments, including a clearer route to market through joint advice and parallel approvals with NICE, alongside a route for international reliance for medicines and medical devices so patients benefit sooner from cutting-edge innovation.
A world-first regulatory framework for Decentralised Manufacturing came into effect on 23 July, giving the NHS and innovators of personalised medicines a clear and safe way to bring the production of advanced treatments from the lab to a patient’s bedside. The new regulations strengthen the UK’s leadership in safe, decentralised manufacturing and is expected to boost research, trials and patient-access to cutting-edge treatments.
Detailed guidance and a webinar recording were published last month, following work with other UK regulators, the NHS, industry, academics and healthcare professionals to provide clarity around how the regulation applies in practice. Further information about how to apply for a decentralised manufacture designation has now been added.
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We have set out our intention to enable earlier access to innovative medical devices that address unmet clinical needs within the NHS. This forms part of the MHRA’s wider contribution to the UK Government’s Life Sciences Sector Plan and the 10-Year Health Plan and supports the UK’s ambition to be a global leader in medical device innovation. The Early Access service will use learnings from the Unmet Clinical Need Authorisation (UCNA) tool piloted in the Innovative Devices Access Pathway (IDAP), and be shaped by stakeholder engagement with key sector representatives. For more information see our Statement of Policy Intent and our news story.
We are pleased to announce that we have published our MHRA 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.
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From 1 August 2025, matters related to compliance with the labelling requirements under the Windsor Framework for medicines will be managed through MHRA business as usual processes, rather than via the MHRA Partnerships mailbox. These should be submitted through the usual process as Type II Pharmaceutical (batch specific) variations if requesting a single or small number of batches of product to be released outside of the usual conditions of the marketing authorisation. These variations will be assessed by the Product Information Quality unit and queries may be directed to the team at: Patient.Information@mhra.gov.uk.
For products that have already been QP certified and later found to be non-compliant with the labelling requirements of the Windsor Framework, please continue to contact the Defective Medicines Report Centre (DMRC) at DMRC@mhra.gov.uk.
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Our Clinical Trials hub on GOV.UK contains draft guidance to support the implementation of the new Clinical Trials Regulations that come into effect on 28 April 2026. We have been working closely with the Health Research Authority, and when appropriate, we have included links to their guidance.
We have already shared this draft guidance with a small group of interested and involved members of the clinical trials community and sought their immediate feedback. Now it is ready for the wider clinical trials community to access. Review the new draft guidance.
 This month we launched a consultation with UK stakeholders to gather feedback and comments on a new international guideline on the design, conduct, analysis, and interpretation of adaptive clinical trials (International Council for Harmonisation Guidelines E20). We are also consulting with UK stakeholders to gather feedback and comments on another guideline (International Council for Harmonisation Guidelines E21) for the appropriate inclusion and/or retention of pregnant and/or breast-feeding individuals in clinical trials of medicines.
 We are also inviting feedback on the operation and impact of the human medicines and medical devices legislation as part of a statutory review required under the Medicines and Medical Devices Act 2021. We would value your views and experiences on the regulations which are relevant to you or your organisation. Please provide us with specific examples where possible.
You can write to us, email us or call us to get in touch with the MHRA. Find out how near the bottom of our homepage.
For any comments and feedback on this newsletter, please email: info@mhra.gov.uk.
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