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Growth in UK clinical trials

The UK’s ambition to strengthen its position as a leading destination for global clinical research is beginning to show results. According to a recent MHRA publication, clinical trial applications submitted between January and November 2025 were 9% higher than during the same period in 2024, with particularly notable increases in:

  • Trials in healthy volunteers (+16%)
  • First‑in‑human studies (+5%)
  • Trials being run in the UK for the first time (+7%)

The publication notes that “growth was strongest in early and innovative research, where speed and expert regulatory support can make or break decisions on where companies invest.”Continue Reading UK Clinical Trials Reform: Early Growth Indicators and Key MHRA Guidance

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2025 from the the United Kingdom, and European Union.Continue Reading Virtual and Digital Health Digest – November 2025

A new policy paper released on 2 November 2025 sets out the MHRA’s proposals on overhauling and transforming the UK regulation of rare therapies.

The intention is for a “bold new rulebook for rare therapies” to be published in 2026. Rare therapies is defined as medicinal products intended to treat rare diseases, specifically, conditions with a prevalence of no more than 5 in 10,000. The Medicines and Healthcare products Regulatory Agency (MHRA)’s press release on the matter provides the concerning statistic that, while ≈3.5 million people in UK are affected by rare diseases (equivalent to one child in every classroom), and many more if carers are taken into account, only 5% of rare diseases have approved treatment. An intention of the reform is therefore to shorten the time for development of therapies for such conditions from initial discovery through to the stage of delivery to patients.

The MHRA aims to position the UK as a global leader in developing, regulating, and integrating rare therapies into healthcare. This policy paper outlines a new regulatory framework designed to accelerate access to innovative treatments for rare diseases while maintaining safety and evidence standards.

The initiative is supported by the newly formed Rare Disease Consortium, a collaborative effort made up of various different stakeholders including the MHRA, NICE, DHSC, NHS England, as well as patients and their representatives, academia and research institutions and industry.

A draft of the framework is anticipated to be available by Spring 2026, with external review in the first half of the year. A public consultation will also be conducted in 2026.Continue Reading Rewriting the Rulebook: MHRA’s Vision for Rare Disease Therapies

On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned Pathway”. This is a joint initiative designed to streamline  the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA). The pathway supports the UK Government’s ambitions outlined in the 10-Year Health Plan for England and the Life Sciences Sector Plan to accelerate access to medicines and reduce regulatory burden, as discussed in our blog here.Continue Reading MHRA and NICE launch aligned approvals pathway

On 31 July 2025, the UK government published a statement of policy intent, setting out its initial thinking on an Early Access Service (EAS) for innovative medical devices. The intention is for this to first focus on innovative diagnostic devices, particularly those supporting the NHS’s most urgent needs and financial sustainability in the NHS.  It is hoped this will lead to quick market access of such devices, by addressing challenges associated with generating sufficient evidence to obtain regulatory approval.Continue Reading UK proposes Early Access Service for innovative medical devices

The UK government has published its response to the recent consultation on the UK Medical Devices Regulations. As highlighted throughout the process to date, the focus is on improving regulatory scrutiny and oversight of medical devices and IVDs in the UK. Changes are aimed at closer alignment with international best practice and to ensure that Great Britain has risk proportionate regulations. Changes are not intended to introduce the EU Medical Devices Regulations into UK law, although there are of course similarities, which has been welcomed by those responding to the consultation.

There were four key areas under consultation: (1) International reliance, (2) UKCA marking, (3) IVD devices, and (4) Assimilated EU law. We have set out a summary on each of these below.Continue Reading UK Medical Devices Regulations: further changes afoot

On 16 June 2025, the UK Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 came into force, marking the first step in the reform of the UK legislation for medical devices. The regulations apply to Great Britain (England, Wales and Scotland), and medical devices placed on the market in Northern Ireland must follow…

On 11 April 2025, the MHRA announced  that the much anticipated changes to the clinical trial rules in the UK, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (the new Regulations), have been signed into law.

In January, we posted a detailed blog on the upcoming changes to the UK law governing clinical trials, noting that this had been described as the “biggest overhaul of the clinical trial regulations in 20 years”, and is intended to cement the UK as a world-class destination for conducting international clinical trials, to “support [a] more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants.”

The new Regulations will come into effect on 10 April 2026, following a 12 month roll out period. The MHRA states in its announcement that it is “committed to implementing a flexible and risk-proportionate regulation of clinical trials, which accelerates patient access to potentially life-saving medicines without compromising safety.”Continue Reading Recent updates on reform of UK clinical trial landscape

On 3 February 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation asking for stakeholders’ views on  draft guideline in relation to the regulation of individualised mRNA cancer immunotherapies (Draft Guideline).

The aim of the proposed guideline is to establish a clear and streamlined regulatory pathway to authorisation so that these highly innovative products can be made available to patients quickly, without compromising any assessment of safety. While the primary focus of the Draft Guideline is individualised messenger Ribonucleic Acid (mRNA) cancer immunotherapies, MHRA suggests that the regulatory and scientific principles considered might be broadly applicable to other disease indications (including rare diseases) or technologies that could benefit from personalisation or individualisation. It also states that the Draft Guideline will be updated when experience of other technologies (peptides, non-integrative DNA and polymer deliver systems) is available.  

In terms of regulatory assessment of individualised mRNA cancer immunotherapies, the Draft Guideline provides clarification of the data which should be included in marketing authorisation (MA) applications and, importantly, confirms that an individualised medicine may, in some circumstances, be granted an MA under the Human Medicines Regulations 2012 (HMRs), even where the product includes an individualised component tailored to the requirements of a specific patient.

There is currently substantial interest in the use of mRNA technology to develop individualised treatments for cancer. The current consultation is therefore of interest to companies focussing on this and other individualised therapies.Continue Reading The UK’s MHRA launches consultation on draft guideline on individualised mRNA cancer immunotherapies

As set out in our previous post, the Innovative Licensing and Access Pathway (ILAP) is an initiative aimed at bringing innovative medicines to the UK market more quickly. On 30 January 2025, the MHRA launched a new version of ILAP in response to feedback from stakeholders.

The first version was launched in January 2021, shortly after the end of the Brexit transition period. It enabled developers to work collaboratively with the NHS, MHRA, and UK Health Technology Assessment (HTA) bodies to bring their product to the UK market in a more streamline and efficient way, benefiting from tailored guidance and support as well as shorter timelines. The scheme saw high levels of applicants, but also faced criticism from stakeholders for a lack of clarity, overly permissive entry criteria and a lack of direct NHS involvement.Continue Reading The new UK Innovative Licensing and Access Pathway – relaunched, refined, refreshed