The UK is ramping up efforts to become a global first choice for clinical trials, as new figures\u00a0published today (13\u00a0January),\u00a0show a sharp rise in activity\u00a0in 2025,\u00a0and changes coming this year\u00a0\u2013\u00a0including a fast-track route\u00a0\u2013\u00a0that will help companies get studies up and running\u00a0more quickly, so patients can benefit from new treatments sooner.\u00a0<\/p>\n
Data from the Medicines and Healthcare products Regulatory Agency (MHRA) shows clinical trial applications\u00a0received\u00a0rose by 9 per cent\u00a0between\u00a0January and November\u00a02025 compared with\u00a0the same period\u00a0in 2024. Growth was strongest in early and innovative research, where speed and expert regulatory support can make or break decisions on where companies invest.\u00a0<\/p>\n
For example, trials involving healthy volunteers \u2013 often the first step in testing whether a new medicine is safe \u2013 increased by 16 per cent, alongside rises in trials testing treatments in people for the first time\u00a0(5 per cent), and those being run in the UK for the first time\u00a0(7 per cent), a sign of growing international confidence in the UK as a place to launch new research.\u00a0<\/p>\n
Companies are also coming to regulators earlier for help.\u00a0The number of MHRA\u00a0scientific advice meetings\u00a0provided\u00a0on clinical trials\u00a0rose by 75 per cent over that period, as developers seek to design trials right first time and avoid costly delays\u00a0later on.\u00a0<\/p>\n
These\u00a0impressive\u00a0gains have been made within the\u00a0limitations of the\u00a0current\u00a0regulatory framework.\u00a0A package of\u00a0significant changes\u00a0will be delivered\u00a0with new clinical trial\u00a0regulations\u00a0due to take effect\u00a0from April.\u00a0Under\u00a0the new rules,\u00a0around one in five studies\u00a0are\u00a0expected to move onto a fast-track\u00a0notification route, which\u00a0will allow lower-risk trials to start sooner, while\u00a0maintaining\u00a0high safety standards and freeing up experts to focus on complex and early-phase studies. The\u00a0MHRA\u00a0will\u00a0also\u00a0introduce\u00a0a\u00a014-day assessment route for phase 1 trials,\u00a0adopting an innovative\u00a0stepwise approach,\u00a0restoring a rapid pathway for the earliest testing of new medicines in people \u2013 a key draw for global developers deciding where to base their research.\u00a0<\/p>\n
Alongside faster assessments, the\u00a0new framework will support\u00a0clearer, more agile routes to support innovation. This includes making better use of early safety data from overseas studies that meet UK standards, and new\u00a0MHRA\u00a0capability to assess computer model\u00a0simulations,\u00a0such as in-silico trials,\u00a0to help predict how new medicines may behave before they are tested\u00a0in patients. The aim is to reflect how modern medicines are developed today, without lowering safety standards.\u00a0<\/p>\n
More broadly, patient participation in clinical research is now higher than before the pandemic. Across England,\u00a0more than 450,000 people took part in studies last year<\/a>, underlining the role trials play in giving patients access to new treatments.\u00a0<\/p>\n Together, the reforms\u00a0strengthen the UK\u2019s offer to global life sciences developers\u00a0as\u00a0a\u00a0safe,\u00a0fast place to start high-quality clinical trials. They support the Government\u2019s ambition to\u00a0cut the time from trial application to first participant to 150 days<\/a>. The reforms also align with wider Government action to modernise the research system through the\u00a010 Year Health Plan\u00a0for England<\/a>.\u00a0<\/p>\n The figures build on consistently strong regulatory performance. Research published in the\u00a0British Journal of Clinical Pharmacology\u00a0in October 2025\u00a0shows that 99 per cent of clinical trial applications\u00a0received by the MHRA\u00a0are reviewed on time, with most completed\u00a0well ahead of target<\/a>\u00a0\u2013 giving\u00a0trial sponsors greater certainty when planning studies in the UK.\u00a0<\/p>\n Health Innovation Minister Dr\u00a0Zubir\u00a0Ahmed said:<\/strong><\/p>\n 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.\u00a0<\/p>\n 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.\u00a0<\/p>\n 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.<\/p>\n<\/blockquote>\n MHRA Chief Executive Lawrence Tallon said:<\/strong><\/p>\n Clinical trial sponsors are clear about what they need: speed,\u00a0clarity\u00a0and flexibility.\u00a0We\u2019ve\u00a0made practical improvements that are helping trials move through the system more smoothly.\u00a0The biggest shift is still to come.\u00a0New rules will\u00a0make it simpler to start lower-risk studies, strengthen support for early-stage research and\u00a0embrace\u00a0modern approaches, including adaptive trial designs and computer\u00a0model simulations, while\u00a0maintaining\u00a0patient safety.\u00a0<\/p>\n 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.\u201d\u00a0<\/p>\n<\/blockquote>\n Chief Scientific Adviser at the Department of Health and Social Care (DHSC) and Chief Executive Officer of the NIHR,\u00a0Professor Lucy Chappell,\u00a0said:<\/strong><\/p>\n 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.\u00a0<\/p>\n The UK is making real progress in streamlining and reducing delays and freeing up capacity\u00a0in order to\u00a0deliver research. The MHRA\u2019s commitment to enhancing the efficiency and quality of trial set-up is playing a pivotal role in this progress, ensuring that\u00a0new studies\u00a0can be launched swiftly without compromising safety or standards.<\/p>\n<\/blockquote>\n The reforms are being highlighted as MHRA Chief Executive Lawrence Tallon\u00a0attends the J.P. Morgan Healthcare Conference in San Francisco this week, alongside\u00a0Health Minister\u00a0Zubir\u00a0Ahmed and DHSC\u00a0Chief Scientific Adviser, Professor Lucy Chappell,\u00a0as part of a UK Government delegation\u00a0to\u00a0engage\u00a0global 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.\u00a0<\/p>\n Notes to editors\u202f\u00a0<\/p>\n Manfrin\u00a0A.\u00a0et al. (2025) Evaluation of the MHRA\u2019s introduction of a risk-proportionate approach for clinical trials: an analysis of 4617 applications assessed between September 2023 and August 2024.\u00a0British Journal of Clinical Pharmacology. DOI:\u00a010.1002\/bcp.70308<\/a>.\u00a0<\/p>\n<\/li>\n The Medicines and Healthcare products Regulatory Agency (MHRA)\u00a0is responsible for\u00a0regulating 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.\u202f\u00a0<\/p>\n<\/li>\n The MHRA is an executive agency of the Department of Health and Social Care.\u202f\u00a0<\/p>\n<\/li>\n\n
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