The Medicines and Healthcare products Regulatory Agency (MHRA) has established the UK National Commission on the regulation of artificial intelligence (AI) in healthcare to develop a new regulatory framework for artificial intelligence in healthcare. The main objective is to transform the NHS into the most AI-enabled healthcare system in the world.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the establishment of a hub in Northern Ireland, hosted by Invest Northern Ireland at its Belfast offices. The hub will provide local stakeholders in the healthcare and life sciences sectors with periodic in-person surgery sessions with MHRA technical experts to discuss innovation pathways, clinical investigations and be directed to further regulatory support available from MHRA throughout the product development pipeline. The initiative is intended to support clinical research and the development of new therapies and builds on commitments made following an MHRA Board meeting in Belfast in November 2025. Northern Ireland's life sciences sector comprises approximately 250 businesses, supports around 18,000 jobs and contributes an estimated £1.1 billion to the local economy.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on clinical investigations for medical devices to extend its fee waiver programme for micro and small enterprises into 2026–27. The programme will run from 20 April 2026 until 5 April 2027 or until all fee waivers are granted and will offer 10 clinical investigation application fee waivers for eligible UK enterprises. The updated programme now includes Class III devices alongside Class I, IIa and IIb devices but excludes active implantable devices. To qualify, applicants must demonstrate that their device meets 'innovative device' criteria including being new or a novel modification of existing technologies with no regulatory-approved solutions fulfilling the same clinical need in the UK and must obtain micro or small enterprise status from the MHRA prior to application. The programme aims to support patient access to innovative devices by removing regulatory cost barriers for smaller enterprises.

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted its first approval for a product through the new International Recognition Procedure (IRP) launched in January 2024. The product, a new formulation for XGEVA (denosumab), was authorised in only 30 days. The MHRA's utilisation of the new IRP allows the Agency to accelerate the assessment of new medicines by taking into account the expertise and decision-making of trusted regulatory partners in the authorisation process. As a result, medicines that have been approved in other countries with stringent regulators will get to UK patients without delay, aiming to obtain a more rapid, efficient, and cost-effective process for life sciences companies. For XGEVA, the European Medicines Agency initially reviewed the product which received a positive opinion on 25 January 2024 which was taken into account by the MHRA as part of its own review.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on plans to streamline the assessment of some substantial modifications to clinical trial approvals. Although these modifications are referred to as 'substantial', they do not introduce significant new safety concerns and are subject to a risk-proportionate review instead of a full assessment. The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 established two types of substantial modifications to studies that require authorisation. Section 11B sets out the criteria for what constitutes Route B substantial modifications. Companies that apply for Route B modifications will automatically receive approval within 14 days unless the licensing authority intervenes. The agency's commitment to the timeline may result in a staged rollout if the pilot program is oversubscribed. The regulations that create Route B will come into force in April 2026, but MHRA is encouraging companies to take part in a pilot project that is scheduled to start in October 2025 and finish at the end of March 2026.

On 1 April 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) organized a conference with the academic leads of the CERSIs and government funding partners, including MHRA, Innovate UK, the Office for Life Sciences, and the Medical Research Council. The CERSIs, launched earlier in the year with £6.2m in funding (up to £1m per CERSI), gathered to discuss their focus areas and progress in establishing projects aimed at advancing regulatory science in the UK. For instance, the University of Liverpool will spearhead a project on pharmacogenomics, while Brunel University of London aims to transform regulation to introduce more AI-driven healthcare products in the UK. In summary, the CERSIs are concentrating on AI integration, streamlining in silico trials, pharmacogenomics and diagnostic advancements, collaborative laboratory approaches to address cell and gene therapy challenges and digital tools for modernizing manufacturing. All CERSIs will also focus on data sharing, enhancing training and expertise and involving patients and the public.

The Medicines and Healthcare products Regulatory Agency (MHRA) has brought into force the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, marking the first major reform to post-market surveillance (PMS) legislation for medical devices in Great Britain.

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that four members of an organised criminal group have been sentenced following an investigation by its Criminal Enforcement Unit (CEU) into the illegal online supply of controlled drugs, prescription-only medicines (POMs) and unauthorised medicinal products. The investigation linked the group to almost two million doses of medicinal products, including diazepam, clonazepam, lorazepam, alprazolam, codeine, zolpidem and zopiclone, supplied to customers across the UK. The court heard that the defendants prioritised profit over patient safety by supplying medicines without appropriate clinical oversight or safeguards, exposing members of the public to potentially serious health risks. The case was prosecuted by the Crown Prosecution Service's (CPS) Serious Economic Organised and International Directorate (SEOCID).

Life Sciences analysis: Harriet Hanks, Counsel, Andrew Austin, partner, Sofia Schaffgotsch, associate, and Honor May, trainee, at Freshfields Bruckhaus Deringer discuss the Medicines and Healthcare products Regulatory Agency’s (MHRA) Roadmap towards the future regulatory framework for medical devices, published on 9 January 2024.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a final call for marketing authorisation holders to comply with new Windsor Framework arrangements for medicines by 31 December 2024. From 1 January 2025, MHRA will license all medicines in Northern Ireland under a UK-wide licence, requiring 'UK Only' labelling. The EU Falsified Medicines Directive will no longer apply in Northern Ireland, and the UK's 'SecurMed' system will close. MHRA has provided two submission routes for updated artwork and implemented transition measures for pre-2025 medicines.

The Medicines and Healthcare products Regulatory Authority (MHRA) has issued guidance for wholesalers and manufacturers producing human medicines on implementing the Windsor Framework. The Windsor Framework sets out measures, in force from 1 January 2025, which create a framework for human medicines to be licensed on a UK-wide basis and disapplies the EU Falsified Medicines Directive (FMD) safety features for medicines supplied in Northern Ireland. The MHRA provides guidance for Qualified Persons (QPs), Responsible Persons and Responsible Person for Import and focuses on the application of the ‘UK Only’ label, early release to market, UK- and EU-based QPs in the context of the FMD and the Northern Ireland MHRA approved route.

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the regulatory classification of point-of-use hospital water filters for the UK market, as well as advice for suppliers and procurers of such products. Point-of-use water filters are fitted to access points for tap water, such as faucets and showerheads, in the healthcare environment in order to reduce bacterial contamination and decrease the associated risks. The MHRA has made clear that such filters are not considered medical devices, and so do not fall under the legislation for medical device and should not have markings of conformity (ie UKCA/CE UKNI/CE marks) affixed to them. Misuse of such marks can lead to compliance actions under the Medical Devices Regulations 2002, SI 2002/618, reg 51.