The Medicines and Healthcare products Regulatory Agency (MHRA) set out on 13 January 2026, the next phase of reforms aimed at strengthening the clinical trial landscape in the UK.
These reforms come at a time of renewed momentum for clinical research. According to the MHRA, patient participation has recovered strongly and now exceed pre-pandemic levels. During 2025, more than 450,000 people took party in clinical studies across England.[1]
Our analysis of the changes and stakeholder reaction can be found below. If you require more detailed insight on the MHRA and how the reforms will impact your business, please contact Brevia Health (+44 (0)20 7091 1655 or email contact@breviahealth.com).
Clinical Trials in 2025
New data from the MHRA shows a significant increase in clinical trial activity during 2025 compared to previous years. Clinical trial applications rose by 9 per cent between January and November 2025, compared with the same period in 2024.[2] The strongest growth was seen in early-stage and innovative research.
A breakdown of this growth shows that:[3]
- Trials involving health volunteers increased by 16 per cent.
- Trials testing treatments in people for the first time increased by 5 per cent.
- Trials being run in the UK for the first time increased by 7 per cent.
The MHRA also reported a 75 per cent increase in the number of scientific advice meetings on clinical trials between January and November 2025. This suggests that companies are engaging with regulators earlier in the development process and seeking to design high-quality trials from the outset.[4]
New Reforms for 2026
From April 2026, new clinical trial regulations are set to come into force. Key changes include the introduction of a fast-track notification route that allows lower-risk trials to begin more quickly. This will enable safety experts to focus resources on more complex and early-phase studies while maintaining high safety standards.
The MHRA also plans to introduce a 14-day assessment route for phase 1 trials, restoring a rapid pathway for the earliest testing of new medicines in humans.
The new regulatory framework will also provide clearer and more agile routes for innovation, including:
- The use of early safety data from overseas studies that meet UK standards; and,
- New MHRA capability to assess computer model simulations, such as in-silico trials, to help predict how new medicines may behave before they are tested in patients.
Together, these reforms strengthen the UK’s position as a safe and efficient place for global life sciences developers to initiate high-quality clinical trials. They support the Government’s ambition to cut the time from trial application to first participant to 150 days and align with wider efforts to modernise the research system through the 10 Year Health Plan for England.
Stakeholder Reactions
Health Innovation Minister, Dr Zubir Ahmed MP said:
“These improvements mean we are making it even easier for companies to bring clinical trials to the UK, offering a single point of support, faster processes, and a more predictable pathway to launch studies.”
MHRA Chief Executive, Lawrence Tallon said:
“New rules will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace modern approaches, including adaptive trial designs and computer model simulations, while maintaining patient safety.”
Chief Scientific Adviser at the Department of Health and Social Care (DHSC) and Chief Executive Officer of the NIHR, Professor Lucy Chappell, said:
“Accelerating the set-up of clinical trials is critical to keeping the UK at the forefront of research on the global stage. When trials can start more quickly and predictably, sponsors are more confident in investing in the UK, meaning our R&D landscape can thrive and we can ensure better outcomes for patients.”
Next Steps
Following a 12-month implementation period that began in April 2025, the new clinical trial regulations will come fully into force on 10 April 2026. Developed by the MHRA and the Health Research Authority (HRA) in collaboration with patients, researchers, clinicians, and industry, the reforms mark a shift towards a more agile and attractive UK clinical research environment, with the potential to accelerate innovation and patient access to new medicines.
[1] Medicines and Healthcare products Regulatory Agency, ‘Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation’, 13 January 2026, Link
[2] Medicines and Healthcare products Regulatory Agency, ‘Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation’, 13 January 2026, Link
[3] Medicines and Healthcare products Regulatory Agency, ‘Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation’, 13 January 2026, Link
[4] Medicines and Healthcare products Regulatory Agency, ‘Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation’, 13 January 2026, Link
