New regulations for the conduct of clinical trials in the UK have now been signed into law.
With the global clinical trials market expected to nearly double to over £80 billion by 2032, making the UK a more attractive place to deliver high-quality, innovative research is important not only for patients, but also the NHS and the UK economy more widely.
With the aim of strengthening patient safety, bringing in faster and more streamlined approvals, enabling innovation and helping more people benefit from taking part in research, this is the most significant update to UK clinical trials regulation in two decades.
The new regulations were developed by the Medicines and Healthcare products Regulatory Agency (MHRA), in partnership with the Health Research Authority (HRA), and shaped by feedback from patients, researchers, doctors, and industry.
The statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 was laid before Parliament in December 2024. The updated regulations will come into full force from 10 April 2026 after a 12 month implementation period which is now underway.
Background to the updated Regulations
The Government, the MHRA and the HRA have worked together for the past two years to produce draft proposals that update the Medicines for Human Use (Clinical Trials) Regulations 2004 ("the Regulations"). This has been described as the “biggest overhaul of the clinical trial regulations in 20 years”. A public consultation on the proposed changes took place in 2022, with the Government providing its response to the consultation in 2023.
In drafting these changes, the Government's key sector and regulatory objectives include: global competitiveness, regulatory flexibility and proportionality and reducing the regulatory burden. The HRA has said "the new legislation […] is intended to support more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants."
The updated regulatory framework was also designed to align with Lord O'Shaughnessy's recommendations following his independent review of UK commercial clinical trials, published in May 2023, and the Government's response to those recommendations. Lord O'Shaughnessy's report noted that in recent years the UK has experienced a decrease in commercial clinical trials activity and falling numbers of clinical trials being initiated.
Key changes
Some of the key changes include -
- Simplified consent for lower risk clinical trials
The new Regulations will make it easier to seek and record consent in 'lower risk' clinical trials, ie those involving medicines that have already been approved. The HRA recently ran a consultation on simplifying this process.
- Research Ethics Committees, combined reviews and approval processes
The new Regulations streamline approval procedures and increase alignment with the EU's clinical trial regime. The previously separate applications for MHRA and ethics approvals will be combined into a single review application. The new Regulations will also remove onerous requirements and increase flexibility for the constitution of RECs. It is hoped that these changes will accelerate the start of clinical trials and make it easier to comply with statutory timeframes for regulatory assessments.
Of note, the new Regulations will also include a sunset period regarding trial approvals. The effect of this will be that an approval will lapse after a period of two years if no participants have been enrolled and no extensions have been granted.
- Greater transparency
The proposed changes will require companies to register clinical trials in a WHO recognised public register and to publish a summary of results within 12 months of the end of the trial. This is similar to the process set out in the 2022 EU Clinical Trial Regulations. The purpose of this change is both to reaffirm public trust in clinical research and enable the scientific community better access to scientific data. There will of course be exemptions to transparency such as for confidential information or reasons of national security.
- Good clinical practice
The updated Regulations will require compliance with the overarching principles of good clinical practice (GCP) in order to align with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. This establishes compliance with international standards. However, compliance with the entirety of the guidelines will not become a legal requirement in the UK although that may in practice be necessary if the data generated from the trial will be used in other countries.
- Manufacturing and assembly
The new Regulations include a definition of ‘non-investigational medicinal product’ (NIMP) as “a medicinal product used or to be used in a clinical trial, as described in the protocol, but not as an investigational medicinal product”. Including the definition in the legislation, rather than in the guidance as it is currently, aims to provide assurance in relation to the quality and safety of these products. Certain requirements will apply to these products, including compliance with GMP and labelling requirements. There will also be greater flexibility to the requirements for labelling of licensed medicinal products used in clinical trials, where this is considered appropriate.
New guidance and next steps
Work to bring in the new rules will continue over the coming months, backed by updated guidance and ongoing engagement with trial sponsors and researchers.
The HRA and MHRA are drafting guidance to clarify what the expectations are for research carried out in the UK. To give a flavour of what can be expected from the guidance, the HRA have said that, following their consultation in 2022, they are "leading on producing guidance to ensure clinical trials represent a diverse population, and involve members of the public in the design, conduct and dissemination of research".
New analysis published of UK clinical trial landscape
The regulatory reform builds on a major review just published of the nature of clinical research in the UK.
Over 4,600 clinical trial applications submitted to the MHRA between 2019 and 2023 have been analysed highlighting where there are opportunities and work to be done that can shape the future of medical research and patient care.
The report, featured in the British Journal of Clinical Pharmacology, provides a detailed picture of the UK's clinical trial landscape, highlighting where there is strong innovation and identifying key opportunities.
The main findings include that:
- The UK is a hub for pioneering research, with one in eight trials testing treatments in humans for the first time.
- There is strong commercial investment, with 85% of trials industry-sponsored.
- Cancer trials dominate, making up nearly a third of all studies, while other major diseases, such as heart disease, receive less focus. Chronic pain, respiratory conditions, and mental health disorders are among the least researched, despite their significant impact on public health.
- Cutting-edge treatments, such as gene and cell therapies, represent a growing clinical area but make up only 3.4% of trials.
Conclusion
The MHRA is using these insights to build upon the country’s world-leading clinical research. The new clinical trials regulations can create a more efficient, streamlined and adaptable regulatory framework and the MHRA has shown it is committed to implementing a flexible and risk-proportionate regulation of clinical trials.
The new framework supports the Prime Minister’s target to reduce the time from submitting a clinical trial application to the first participant taking part from 250 to 150 days. This in turn will speed up research and reduce the time it takes for promising treatments to reach patients, while ensuring safety. This should be positive news for those conducting clinical trials in the UK and considering the UK as a venue for their research.
