LONDON, April 28 -- The government of the United Kingdom issued the following news:
The Medicines and Healthcare products Regulatory Agency (MHRA) met or exceeded all statutory targets to increase access to medicines and medical devices for UK patients, according to the MHRA Results and Forecast reportpublishedtoday (28 April).
TheMHRAhasstrengtheneditspositionasaworld-leading medicines regulator by striking new global partnerships and advancing pioneering work in clinical trials reform, AIregulation,and rare disease therapeutics pathways.It continues to speed up access to medicines for patients, increase efficiency of regulation and help to attract innovation and investment in the UK's thriving £100 billion life sciences industry.
It continues to speed up access to medicines for patients, increase efficiency of regulation and help to attract innovation and investment intheUK'sthriving£100 billion life sciences industry.
Building on thisstrong performanceover the last year, the MHRA will launch a new five-yearstrategylaterthisyear,settingouthow UK regulation will continuetoevolve to support patient safety, NHS priorities, scientific innovation, and economicgrowth in the UK life sciences sector through to 2030.
TheMHRAResultsandForecastreport showsthatin the 2025/2026 financialyear, the MHRA:
Strengthenedpatientandpublicsafety:
Tacklinghealthmisinformation,introducingstrongerpost- market surveillance rules for medical devices, removingnearly 28 million unauthorisedmedicine doses and modernising safety monitoring through enhanced vigilancesystems.
Hitallitsperformancetargets:
Deliveringagainsteverystatutorycommitment,meetingallkeyperformance indicators with excellent on-time performance across licensing, clinical trials, and safety decisions.
Endedtheyearinfinancialsurplus:
Closingtheyearinastrongfinancialposition,achievingahealthysurplusthat reflects improved stability and disciplined operational delivery.
Ledinkeyareasofregulatoryscience:
Strengtheninggloballeadershipinregulatoryscience,investinginAI,in-silicoresearch,and innovative methodologies, while advancing pioneering work in clinical trials reform, AIregulation,and rare disease pathways.
Builtclosernationalandinternationalpartnerships:
StrengtheningcollaborationacrosstheUKandglobally,includingtheMHRA-National Institute for Health and Care Excellence's (NICE) aligned pathwayto accelerate patient access, a newUK-Singapore Innovation Corridor, inaugural membership of theHealthAI networkandcollaboration with the US FoodandDrugAdministration (FDA) on medicinal deviceregulationaspartof the wider US-UK pharmaceutical partnership.
Enjoyedanincreaseinexternalsentiment:
Demonstrating a sustained improvement in externalperception, with independent research showing more positive views among industry, partners, and system stakeholders over the past 12-18 months.
Andalsoariseinstaffmorale:
Increasedstaffengagement,withrecordparticipationinthestaffsurvey, and a significant improvement in the Engagement Score, reflecting a more motivated and growing workforce.
HealthMinisterDrZubirAhmed,said:
"This past year has shown what a modern regulator looks like: patients first, pace where it matters, and standards that never slip. The MHRA has made tangible progress on this Government's ambitions for the NHS, public health, and the Life SciencesSector Plan.The direction of travel is clear. With the MHRA operating as a high-performance regulator, the UK is positioned as a global destination for life sciences that is open to innovation, serious about safety, and credible on the world stage."
Lord Vallance, Minister for Science, Innovation, Research and Nuclear, said:
"A strong life sciences sector depends on a regulator that is trusted by patients, by clinicians and by innovators. The MHRA isdemonstratingthat trustworthiness through its commitment todelivering forthe NHS, public health, and economic growth. The MHRA's progress and future direction strengthens the UK'sproposition as a global destination for research and development."
LawrenceTallon,MHRAChiefExecutive,said:
"We have a regulatory environmentthat'sscientifically rigorous, agile and has patients at its heart. Whether it's enabling access to the next generation ofmedicines and health technologies or protecting patients from harm, our success is measured not just in frameworks and timelines, but in improved lives.
"With every performance target met, a strong financial position and more innovative medicines reaching patients, this is high quality regulation in practice. It is testament to the dedication of our committed and expert workforce and the strong partnerships we have with the wider UK and global health and life sciences system."
ProfessorAnthonyHarnden,MHRAChair, said:
"Overthepastyear,theMHRAhasdemonstratedwhatregulatoryexcellencelooks like in practice. This progress is the result of the skill, professionalism, and commitment of MHRA staff across science, regulation, digital,policyand services.
"Working across the UK health system with researchers, industry, and international counterparts, I have seen first-hand how collaboration strengthens regulation and accelerates access to safe innovation.
"Globally, the MHRA's contribution to regulatory science is well respected. Our leadership and trustedstandardssupport health systems worldwide.As we look ahead, the MHRA enters the next chapters confident and ambitious that we area regulator the public can trust and the world can rely on."
Stakeholderquotes
Jane Wall, Managing Director of theBioIndustryAssociation (BIA)said:
"The MHRA'sstrong performanceover the past year reflects a regulator that is listening and evolving. The forward-looking initiativesshowcasedin this report - including the development ofanewrarediseasepathway -highlightthevalueof collaborative workingto accelerate innovation and delivering better outcomes for patientsacrossthe UK. We look forward to continuing to collaborate closely with the MHRA to build on this momentum."
ProfessorJonathanBenger,CBEMDFRCSFRCEM,ChiefExecutiveof the National Institute for Health and Care Excellence (NICE) said:
"Continuing improvements to joint working between NICE and the MHRA are creating a more integrated and frictionless pathway from regulation to patient access. By aligning ourexpertiseearlier and more closely, we can support innovation, reduce duplication, and provide clearer, faster routes for effectivenew medicines and technologies to reach patients sooner."
JuliaVitarello,patientadvocateandFounderofMila'sMiracleFoundation,said:
"For families like mine facing rare genetic diseases, progress is measured by by how many sick and dying children can access today's incredible technologiesintime.The MHRA is truly leading the way through action, paving the world's first pathway toward process-based approvals to meet the new very promising era of individualised medicines. If successful, the UK will prove a new bridge connecting patients in desperate need with the science that can save lives."
DrMattWestmore,ChiefExecutiveoftheHealthResearchAgency(HRA),said:
"One of the UK's core strengths in health and care research is our joined up regulatory system. Through close partnership between MHRA, HRA and others, we have streamlined and simplified theapprovalspathway. By reducing duplication and complexity we'regiving researchers a faster, more predictable experience from start to finish.I'mparticularly proud of our work together on Combined Review which continues to go from strength-to-strength, helping patients access potentially life changing research sooner."
RichardTorbett,ChiefExecutive,AssociationoftheBritishPharmaceutical Industry (ABPI), said:
"Overthepastyear,theMHRAhascontinuedtomakeimportantprogressin strengthening the UK's regulatory environment for medicines and vaccines, particularly in the provision of predictableandreliableservices.Improved efficiency around clinical trial approvals, alongside enhanced safety surveillance is also helping to support earlier patient access to innovative medicines while maintaining robust regulatory standards.
"This progress is helping to boost the UK's position as an attractive environment for life sciences research and earlier patient access. It is encouraging to see this momentum in the evolution of the regulatory system, and we hope to see it continue in the years ahead."
PeterEllingworth,CEO,AssociationofBritishHealth TechIndustries(ABHI),said:
"TheMHRA'soutward-looking and collaborative approach is welcome,particularlyits engagement with global partners to drive regulatoryharmonisation. Greater alignment across markets will help reducecomplexityandreinforcetheUK'sposition as a competitive destination for HealthTech innovation and investment. ABHI values its continued engagement with the MHRA and the opportunity to work together to deliver these important reforms."
Lord O'Shaughnessy, former health minister, senior partner atNewmarket StrategyandauthorofthelandmarkreportintotheUKcommercialclinical trials landscape said:
"The progress made since I published my review in 2023 has been remarkable. The MHRA is now delivering consistently good approval times while introducing further reforms that are adding speed and flexibilitytotheprocess.TheMHRAisonceagain taking a global lead, which is helping to attract more clinical trials to the UK."
MichelleRiddallsOBE,CEO,PAGB,theconsumerhealthcareassociationshares:
"Lawrence Tallon's commitment to engaging and collaborating with industry associations has significantly advanced MHRA's understanding of consumer healthcare priorities this year. His leadership hasfacilitatednew opportunities to discuss practical and impactful ways to expand medicine reclassificationand empower self-care.
"Reclassification is a key opportunity to expand access to medicines, support self-care, and reduce pressure on NHS services. MHRA has a real opportunity to accelerate this shift and, through initiatives like the Access Consortium, further drive international collaboration,and innovation."
DrRicardoBaptistaLeite,CEO,HealthAI - The Global AgencyforResponsible AI in Health, said:
"AsthefirstpioneercountryintheHealthAIGlobalRegulatoryNetwork,theUKhas helpedturnresponsibleAIinhealthfromapromiseintoaconcreteglobalambition. By couplingbold reform witha clear commitment tosafety andequity, the MHRA is charting a path that can inspire innovators, regulators and investors worldwide to build AI-powered health systems that truly serve people."
SteveBatesOBE,ExecutiveChairoftheOfficeforLifeSciencessaid:
"In the past year, we have seen the UK's regulatory environment generating real excitement among international stakeholders. The MHRA has been central tothis, driving innovation through more agile, responsive pathways."
AdjunctProfessor(Dr)RaymondChua,ChiefExecutiveOfficer,Health Sciences Authority (HSA), Singapore, said:
"Our longstanding partnership with the MHRA has strengthened through the launch of our Regulatory Innovation Corridor, and refreshed memorandum of understanding. As a globally connected biomedical hub, Singapore is committed to shaping a forward-looking regulatory environment with like-minded partners like the MHRA. Together, we are accelerating innovation inSingaporeandtheUKto deliver transformative technologies to benefit patients, while upholding the highest standards of safety, trust, and excellence."
Notestoeditors:
*
TheMHRA'sResultsandForecastisavailableat:MHRA Results and Forecast 2025/26; 2026/27 - GOV.UK
*
The Medicines and HealthcareproductsRegulatory 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 robustandfact-based judgements to ensure that the benefits justify any risks.
*
TheMHRAisanexecutiveagencyoftheDepartmentofHealthandSocialCare.
*
Formediaenquiries,pleasecontactthenewscentre@mhra.gov.ukorcallon020 3080 7651.
Disclaimer: Curated by HT Syndication.
