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."
The new Regulations follow the publication of the MHRA's first ever analysis of UK clinical trial applications, which identified new opportunities to drive medical breakthroughs for patients. This was undertaken with the University of Liverpool and found that while the UK is a global leader in clinical research, there is a "concentration of research in certain disease areas" and "opportunities for increased representation of certain patient groups".
Crucial findings included that cancer trials dominate the trial landscape in the UK, making up nearly a third of all studies. Heart disease, which is very common, only made up 5.2% of research and surprisingly, despite wide prevalence in the general public, chronic pain, respiratory conditions and mental health disorders were found to be among the least researched conditions.
Furthermore, the UK is lagging behind in research relating to cutting-edge treatments, such as gene and call therapies, which only make up 3.4% of trials. This is despite the clear benefit to these therapies in changing the landscape of patient care and treatment, particularly in complex and/or rare conditions.
The MHRA has described how, as part of the wider clinical trial reform, it is already working to make the UK a more attractive place to do research, through the relaunch of the Innovative Licensing and Access Pathway (ILAP) (see our blog here), through joint guidance with the Human Research Authority on increasing trial participant diversity (update here), and through collaborating with researchers via the Centres of Excellence for Regulatory Science and Innovation (CERSIs) to support more advanced therapy trials.
The new Regulations and the related initiatives being implemented by the UK government are aimed at increasing the attractiveness of the UK as a place to conduct research and make breakthroughs in medicine and science. It is recognised that the safety of patients should not be compromised, but that there are ways to reduce red tape and simplify processes without losing sight of the need for forward thinking regulations and clear guidance. It is hoped that these reforms will create a "proportionate and flexible regulatory environment" as well as "cement the UK as a destination for international trials".
As always, the devil is in the detail. The MHRA will be publishing guidance in the coming months to accompany the new Regulations, aimed at providing support during the transition period and once the new Regulations are in force. This will need to be clear, balanced and easy to understand to enhance the UK's efforts in becoming a global leader in clinical trials for all disease areas.
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