LONDON, April 27 -- The government of the United Kingdom issued the following news:
The Medicines and Healthcare products Regulatory Agency (MHRA)and Health Research Authority (HRA)areintroducingthe largestpackage of reformsin over 20 years. This will includefaster assessment of first in human trialsandthe introduction ofnotifiable trials,a fast-track route to allow lower-risk trials to start soonerand modificationto be approved quicker, whilstmaintainingthehighestsafety standards.
Thereformswill make it simpler to start lower-risk studies, strengthen support for early-stage research and embracenewapproaches,includinguse of early safety data from overseas studieswhichmeetsUK standards andcomputer model simulations which can help to predict how new medicines may behave before they are tested in patients.
The regulatorshavealready made headway towardsdeliveringmore streamlined and efficient approvals, which has contributed to exceedingthe government's ambitious target to reduce clinical trial set-up times to 150 daysas part of its 10-year plan for the NHS.Latest figures showthecontribution of theMHRAand HRAreducingset-up timesfrom 169 days to just 122 daysfor studies going throughcombinedsafety and ethical review.The combined review process conducted by MHRA and HRA takes an average of 41 days, less than half of the time it took a few years ago.
This is good news forpatients andresearchers,enablingnew trialsto be set up more quicklyand improving patient care.Innovations include theRoute B substantial modificationpathwaywhichwas successfully piloted from October 2025 to March 2026 and receivedstrong supportfrom the research community. It offers a faster, risk proportionate way to assess certain substantial modifications that do not introduce new safety concerns.
During the pilot, applications were processed in an average of just sevencalendardays. Over halfof registrations came from commercial sponsors,demonstratingstrong industry engagement. From 28 April 2026, Route B will be legally mandated as part of the new regulatory framework. Under Route B, eligible modifications are automatically approved unless concerns are raised withincalendar14 days to inform the sponsor that a full assessment is being undertaken.
Working in partnership,the MHRAand HRAhavesought the views of patients, researchers,doctorsand industry to inform and develop the new framework.The regulationshave the safety of trial participants firmly at their heart. They willbroaden accessandensuregreatertransparency, including making registration of clinical trials and publication of summary results a legal requirement for the first time.
DrZubirAhmed, Health Innovation and Safety Minister, said:
"This is a landmark moment for patients, researchers, and our thriving life sciences sector that will make a real, tangible difference for thousands of people waiting for new treatments.
"By introducing faster routes for lower-risk trials, embracing modern technology, and making the system simpler to navigate, we are reinforcing the UK's position as one of the most attractive places in the world to invest incutting-edgeresearch.
"The government set itself an ambitious target to cut clinical trial set-up times to 150 days - andI'mproud to saywe'vegone further and faster than that. We have driven those times down to just 122 days from 169 this time last year for commercial trials, meaning patients across the UK are getting the latest, most innovative treatments sooner than ever before."
MHRA Chief Executive, Lawrence Tallon, said:
"These reforms to clinical trial regulationsareaboost both for patients and industry investment in R&D in this country.They will help tomakethe UKa more attractive, internationally competitive destination for both commercial and non-commercial clinical research.Most importantly, patients willbenefitfrom earlier access to thelatest,innovative medicines.
"We have listenedcarefullytothe needsof patients, clinicians,researchers andindustryto ensure we are delivering themostefficient, streamlined approvalsprocesswithout compromising safety."
Chief Executive of the HRA, Matt Westmore, said:
"The updated regulations will bring greater transparency, faster approvals for clinical trials and simpler approaches for low-risk trials - making it quicker and easier to set up and run trials while placing patients at the centre of medical research.
"Not only will the new framework speed up vital research that could lead to innovative and improved treatments for patients, but it will support a streamlined,joined upand proportionate clinical research system. The reforms are designed to speed up access to new medicines and boost the UK life sciences economy by making it easier to do research that people can trust."
The MHRAClinical Trials(CT)Hubprovides clear, practical guidance to help sponsors apply the new regulations.It brings together guidance and recordedwebinarsin one place. Guidance has been shaped by extensive feedback from both commercial and non-commercial stakeholders. You can stay up to date with developments by registering to 'Get emails about this page' on each set of guidance thatyou'regoing to use.
Notes to editors
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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.
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About the Health Research Authority (HRA): We are an arm's length body of the Department of Health and Social Care (DHSC), which means the Government has devolved some of its responsibilities to us.Our vision is for high quality health and social care research today, which improves everyone's health and wellbeing tomorrow.We help realise this by making it easy to do research that people can trust. You can find out more about what we do athra.nhs.uk
Disclaimer: Curated by HT Syndication.
