LONDON, Jan. 13 -- The government of the United Kingdom issued the following news:

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

Data from the Medicines and Healthcare products Regulatory Agency (MHRA) shows clinical trial applicationsreceivedrose by 9 per centbetweenJanuary and November2025 compared withthe same periodin 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 MHRAscientific advice meetingsprovidedon clinical trialsrose by 75 per cent over that period, as developers seek to design trials right first time and avoid costly delayslater on.

Theseimpressivegains have been made within thelimitations of thecurrentregulatory framework.A package ofsignificant changeswill be deliveredwith new clinical trialregulationsdue to take effectfrom April.Underthe new rules,around one in five studiesareexpected to move onto a fast-tracknotification route, whichwill allow lower-risk trials to start sooner, whilemaintaininghigh safety standards and freeing up experts to focus on complex and early-phase studies. TheMHRAwillalsointroducea14-day assessment route for phase 1 trials,adopting an innovativestepwise 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, thenew framework will supportclearer, more agile routes to support innovation. This includes making better use of early safety data from overseas studies that meet UK standards, and newMHRAcapability to assess computer modelsimulations,such as in-silico trials,to help predict how new medicines may behave before they are testedin 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 reformsstrengthen the UK's offer to global life sciences developersasasafe,fast place to start high-quality clinical trials. They support the Government's ambition tocut 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 the10 Year Health Planfor England.

The figures build on consistently strong regulatory performance. Research published in theBritish Journal of Clinical Pharmacologyin October 2025shows that 99 per cent of clinical trial applicationsreceived by the MHRAare reviewed on time, with most completedwell ahead of target- givingtrial sponsors greater certainty when planning studies in the UK.

Health Innovation Minister DrZubirAhmed 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,clarityand flexibility.We'vemade practical improvements that are helping trials move through the system more smoothly.The biggest shift is still to come.New rules willmake it simpler to start lower-risk studies, strengthen support for early-stage research andembracemodern approaches, including adaptive trial designs and computermodel simulations, whilemaintainingpatient 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 capacityin order todeliver research. The MHRA's commitment to enhancing the efficiency and quality of trial set-up is playing a pivotal role in this progress, ensuring thatnew studiescan be launched swiftly without compromising safety or standards.

The reforms are being highlighted as MHRA Chief Executive Lawrence Tallonattends the J.P. Morgan Healthcare Conference in San Francisco this week, alongsideHealth MinisterZubirAhmed and DHSCChief Scientific Adviser, Professor Lucy Chappell,as part of a UK Government delegationtoengageglobal 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 to editors 

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ManfrinA.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.

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The Medicines and Healthcare products Regulatory Agency (MHRA)is responsible forregulating 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. 

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The MHRA is an executive agency of the Department of Health and Social Care. 

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For mediaenquiries, please contact thenewscentre@mhra.gov.uk, or call on020 3080 7651.

Disclaimer: Curated by HT Syndication.