Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation 

The UK is ramping up efforts to become a global first choice for clinical trials, as new figures published today (13 January), show a sharp rise in activity in 2025, and changes coming this year – including a fast-track route – that will help companies get studies up and running more quickly, so patients can benefit from new treatments sooner.

Data from the Medicines and Healthcare products Regulatory Agency (MHRA) shows clinical trial applications received rose by 9 per cent between January and November 2025 compared with the same period in 2024. Growth was strongest in early and innovative research, where speed and expert regulatory support can make or break decisions on where companies invest.

For example, trials involving healthy volunteers – often the first step in testing whether a new medicine is safe – increased by 16 per cent, alongside rises in trials testing treatments in people for the first time (5 per cent), and those being run in the UK for the first time (7 per cent), a sign of growing international confidence in the UK as a place to launch new research.

Companies are also coming to regulators earlier for help. The number of MHRA scientific advice meetings provided on clinical trials rose by 75 per cent over that period, as developers seek to design trials right first time and avoid costly delays later on.

These impressive gains have been made within the limitations of the current regulatory framework. A package of significant changes will be delivered with new clinical trial regulations due to take effect from April. Under the new rules, around one in five studies are expected to move onto a fast-track notification route, which will allow lower-risk trials to start sooner, while maintaining high safety standards and freeing up experts to focus on complex and early-phase studies. The MHRA will also introduce a 14-day assessment route for phase 1 trials, adopting an innovative stepwise approach, restoring a rapid pathway for the earliest testing of new medicines in people – a key draw for global developers deciding where to base their research.

Alongside faster assessments, the new framework will support clearer, more agile routes to support innovation. This includes making better 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. The aim is to reflect how modern medicines are developed today, without lowering safety standards.

More broadly, patient participation in clinical research is now higher than before the pandemic. Across England, more than 450,000 people took part in studies last year, underlining the role trials play in giving patients access to new treatments.

Together, the reforms strengthen the UK’s offer to global life sciences developers as a safe, fast place to start high-quality clinical trials. They support the Government’s ambition to cut the time from trial application to first participant to 150 days. The reforms also align with wider Government action to modernise the research system through the 10 Year Health Plan for England.

The figures build on consistently strong regulatory performance. Research published in the British Journal of Clinical Pharmacology in October 2025 shows that 99 per cent of clinical trial applications received by the MHRA are reviewed on time, with most completed well ahead of target – giving trial sponsors greater certainty when planning studies in the UK.

Health Innovation Minister Dr Zubir Ahmed said:

As a practising surgeon, I know just how crucial it is to harness medical breakthroughs, so patients get the latest and most advanced treatments quickly and safely. This Government is laser-focused on accelerating clinical trial set-up times and cementing our position as global leaders.

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.

Our Plan for Change is working to drive global investment into life sciences and our economy, improve health outcomes and accelerate the development of medicines and therapies of the future.

MHRA Chief Executive Lawrence Tallon said:

Clinical trial sponsors are clear about what they need: speed, clarity and flexibility. We’ve made practical improvements that are helping trials move through the system more smoothly. The biggest shift is still to come. 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.

Together, these reforms will help high-quality trials start sooner, giving patients earlier access to new medicines and making the UK a more competitive place to develop them.

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.

The UK is making real progress in streamlining and reducing delays and freeing up capacity in order to deliver research. The MHRA’s commitment to enhancing the efficiency and quality of trial set-up is playing a pivotal role in this progress, ensuring that new studies can be launched swiftly without compromising safety or standards.

The reforms are being highlighted as MHRA Chief Executive Lawrence Tallon attends the J.P. Morgan Healthcare Conference in San Francisco this week, alongside Health Minister Zubir Ahmed and DHSC Chief Scientific Adviser, Professor Lucy Chappell, as part of a UK Government delegation to engage global life sciences leaders and investors. The UK is setting out a clear offer: a country that is faster to start trials, open to innovation and built for growth.

Notes

1. Manfrin A. et al. (2025) Evaluation of the MHRA’s introduction of a risk-proportionate approach for clinical trials: an analysis of 4617 applications assessed between September 2023 and August 2024. British Journal of Clinical Pharmacology. DOI: 10.1002/bcp.70308.
2. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
3. The MHRA is an executive agency of the Department of Health and Social Care.

source: GOV