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Welcome to your August 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.
 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 some key 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 July 2025 show that 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 the latest data showing an average time for Combined Review determination (including questions raised) of 41 days in June.
Our data show that 100% of national licence applications continue to be assessed within our statutory timescales of 210 days: with an average timescale of 167 days in July.
Higher volumes of Scientific Advice responses in all regulatory service areas were delivered in July as we continue work to address performance issues and clear residual backlogs in providing scientific advice. This has led to a slight increase in the average timescale to deliver written advice. More resources are now available to help clear scientific advice requests and we will provide more information over the coming months as part of our wider work to further develop and enhance our scientific advice services.
In a collaboration with NICE, we have outlined how the UK Government’s 10-Year Health Plan will enable patients in England to receive new medicines 3-6 months sooner. Through a new joint information-sharing agreement, pharmaceutical companies will be invited to engage earlier with both organisations—supporting parallel decision-making on licensing and value assessment.
This enhanced coordination offers developers access to integrated scientific advice and a streamlined pathway that aligns regulatory and Health Technology Assessment (HTA) requirements. The approach is designed to accelerate UK market entry and deliver innovative, life-changing treatments to NHS patients faster.
To benefit, companies are encouraged to register products on UK PharmaScan at least 3 years ahead of expected marketing authorisation.
Secretary of State for Health and Social Care Wes Streeting described the initiative as part of a wider effort to “slash red tape” and “turbocharge economic growth” in the life sciences sector. The joint service supports the government’s smarter regulation agenda, with a target to reduce administrative costs for businesses by 25%.
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Hear directly from MHRA and NICE leaders about how the new collaboration will work in practice. We’ll share insight into how the integrated scientific advice and aligned pathway will work, explaining how industry can access it and the benefits it is anticipated to deliver.
Date: Wednesday 1 October 2025
Time: 14:00–15:15 BST
Register your attendance
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In August 2025 we received designation as a WHO-Listed Authority (WLA) by the World Health Organization (WHO), joining the ranks of the world’s most trusted regulatory bodies. This recognition affirms MHRA’s commitment to the highest international standards in the regulation of medical products and marks a significant milestone for the UK’s leadership in global health.
This achievement is a testament to the UK’s strategic vision for health and life sciences. It aligns with the ambitions set out in the Government’s Life Sciences Sector Plan, to position the UK as a global hub for innovation and enhance the UK’s life sciences industry through cutting-edge science and regulatory excellence.
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Recruitment has begun for a first wave of new, highly skilled digital and data roles at our newly launched Digital Hub in Leeds. This marks a key step forward in our programme to modernise the regulation of medicines and medical devices in the UK.
The new hub, based in the heart of Leeds at Wellington Place, will play a vital role in building our digital capability and expanding our national presence.
On 27 August 2025, our CEO, Lawrence Tallon, and members of the MHRA Executive Leadership Team visited Leeds to meet with the city’s thriving digital health community, local government and university.
Hosted by the University of Leeds and Leeds Academic Health Partnership, the visit brought together innovators, researchers, health and care leaders, and local government to discuss how regulation can move at the pace of innovation.
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New clinical trials regulations were approved by Parliament in April 2025 and come into effect on 28 April 2026, providing a regulatory framework that is agile, innovative, and patient-centred. You can view the new draft guidance in our Clinical Trials hub.
From 28 April 2026, the Route B substantial modification process will be mandatory for all eligible modifications to a clinical trial.
A Route B substantial modifications pilot will run from 1 October 2025 to 31 March 2026.
Sponsors interested in participating should complete a registration form.
Earlier this month we published a summer blog summarising our recent med tech regulatory reform news. The blog includes news of our intention to introduce an early access service, focussing on diagnostics, to help patients benefit from innovations before full regulatory approval, where there is a clear clinical need. The blog also summarises our intentions on international reliance, including plans to streamline approval routes for safe, approved tech from Australia, Canada and the US and a forthcoming consultation on CE marking.
We are inviting health institutions across Great Britain to complete a questionnaire to share experiences of the health institution exemption policy for medical devices - sometimes also referred to as the in-house manufacturing exemption. The policy exempts certain medical devices from meeting the requirements of the Medical Device Regulations when they are manufactured, used or modified by a health institution for use in that institution. The questionnaire is open until 15 September, and will help us understand more about the types and volumes of medical devices the exemption is being applied to, and the sorts of organisations using it.
On 14 August 2025, we announced the approval of teplizumab (Tzield) to delay the onset of Stage 3 type 1 diabetes (T1D) by an average of three years in adults and children aged 8 years and older with Stage 2 T1D. Teplizumab is the UK’s first-ever approved immunotherapy for type 1 diabetes.
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On 28 August 2025, we announced the approval of gepotidacin (Blujepa), a new kind of oral antibiotic pill to treat uncomplicated urinary tract infections (UTIs) in females aged 12 years and older, weighing at least 40 kg.
Uncomplicated UTIs are the most common bacterial infection in women, affecting around half of females in the UK. With drug-resistant bacteria increasing, new treatment options are critical in preventing treatment failure and complications, including sepsis or permanent kidney damage.
On 27 August 2025 we announced the approval of zuranolone (brand name: Zurzuvae) to treat moderate or severe postnatal depression (PND) in adults following childbirth.
Zuranolone is the first oral treatment for postnatal depression approved in the UK.
A new review written in collaboration with leading academic institutions has spotlighted the vaginal microbiome as a promising frontier in women’s health diagnostics and therapeutics. The review, co-authored with researchers from King’s College Hospital London, the University of Liverpool, Ewha Women’s University, and Biowave W Seoul, outlines how microbiome-based diagnostics could transform clinical pathways for a variety of conditions.
We have launched a Cosmetic Breast Augmentation Risk Awareness Tool. This follows an MHRA research study which found there were opportunities to improve risk communication for breast implant surgery. The aim of the tool, which is arranged as a checklist, is to empower the patient to understand the current known risks associated with breast implants and cosmetic augmentation surgery and as an aid for discussion with their surgeon. The Cosmetic Breast Augmentation Risk Awareness Tool should be provided to patients at their first consultation.
We have announced that we are consulting with UK stakeholders to gather feedback and comments on a revised international guideline to capture quality information for the registration and lifecycle management of pharmaceuticals for human use.
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