MHRA Aims to Make the UK a “Global Leader in Clinical Research”
Published Apr 25, 2025
MHRA Aims to Make the UK a “Global Leader in Clinical Research”
Published 25th April 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has strived to make a success of Brexit. While initially faced with a backlog of clinical trial applications, the MHRA has taken huge steps forward. A recent evaluation shows that the UK is now seen as a global leader in clinical research.
We explored how the MHRA has improved the UK’s clinical development regulatory pathway to be efficient, streamlined, and adaptable. This, in turn, makes the UK an attractive location for clinical development.
MHRA Sets Ambitious Goals for UK Clinical Trials
The MHRA announced that it aims to make “the UK one of the best places globally for clinical trials”.
The MHRA has established several foundations to help it ensure patients can benefit from innovative treatments quickly and safely. Based on an analysis of UK clinical trial applications, the MHRA is in a position to achieve this aim.
The MHRA and the University of Liverpool performed the analysis. It was published in the British Journal of Clinical Pharmacology. It provides a detailed overview of the current clinical trials landscape in the UK. Importantly, it helps the MHRA guide future policy and initiatives.
New Clinical Trial Regulations Transform UK Research
The most significant change to the clinical trials arena in the UK for 20 years took effect recently with the introduction of the new Clinical Trial Regulations on 11 April 2025. This new legislation will enable more streamlined approvals.
With a risk-proportionate review system and a combined review for regulatory and ethics approval, bringing new medicines to patients will be easier and faster (see our recent LinkedIn post).Updates to Health Research Authority guidance made in parallel should improve diversity in trial participation, ensuring that clinical trials reflect the populations they aim to serve.
The updated clinical trials legislation is part of a range of new initiatives that take advantage of independence from European Union procedures. MHRA’s Innovative Licensing and Access Pathway (ILAP), relaunched in January 2025, is expected to provide practical support for medicine developers in the early stages of development.
Our recent article focuses on the benefits of ILAP. ILAP offers coordinated advice for innovative medicines from the relevant regulatory bodies, including the MHRA, the National Health Service, and the Health Technology Assessment (HTA) bodies. The scheme is expected to improve clinical trial recruitment and cut study start delays.
Using the UK’s Unique Clinical Research Infrastructure
This sits alongside the unique benefits of the UK clinical infrastructure, including the UK Biobank and the Clinical Practice Research Datalink (CPRD). These provide access to anonymised patient data encompassing 60 million National Health Service users.
The Research Delivery Network aims to widen access to clinical trials, particularly in primary care. And with the release of funding to establish 14 new Commercial Research Delivery Centres across the UK
The UK Government’s investment in life sciences seems to be bearing fruit, and the UK is seen as an exciting hub for running clinical trials. While cancer trials currently represent most clinical trials, cutting-edge treatments, such as cell and gene therapies, also represent a growing area.
Therefore, these products will be ideal candidates to benefit from initiatives such as ILAP. UK investment in seven Centres of Excellence for Regulatory Science and Innovation (CERSIs) will further advance this type of research.
What’s Next for Clinical Trials in the UK?
Understanding the clinical trials landscape is essential to efficiently getting medicines to patients. The MHRA and the University of Liverpool’s new research establishes a baseline for patterns of clinical trial research in the UK and provides the basis for tracking progress.
The findings will inform future funding, policy, and regulation, so it is important for developers to take note: Where will the next opportunities be?
The MHRA has strived to make Brexit a success. Initially faced with a backlog of clinical trial applications, the MHRA has since made huge steps forward. Laying strong foundations puts the UK in a firm place to be a global leader in clinical research, with an efficient, streamlined, and adaptable pathway for development.
DLRC’s expert consultants are carefully monitoring the UK clinical trials environment. We have supported many companies with clinical development and clinical trial submissions.
We are ideally positioned to guide developers and help ensure medicines can get to patients in the most streamlined manner. Contact DLRC via hello@dlrcgroup.com to maximise the potential of your products and company.
