MHRA Aims to Make the UK a “Global Leader in Clinical Research”

The Medicines and Healthcare products Regulatory Agency (MHRA) has strived to make a success of Brexit. Initially faced with a backlog of clinical trial applications, the MHRA has taken huge steps forward. As evidenced in a recent evaluation, the UK is now seen as a global leader in clinical research.  

Here, we look at what the MHRA has done to help make the regulatory pathway for clinical development efficient, streamlined, and adaptable in the UK. This, in turn, makes the UK an attractive location for clinical development.

MHRA Sets Ambitious Goals for UK Clinical Trials

The MHRA has recently announced that it aims to make “the UK one of the best places in the world to run clinical trials”.  

Endeavouring to ensure that patients can benefit from innovative treatments quickly and safely, the MHRA has recently put in place a number of foundations to help meet its ambition. Based on an analysis of clinical trial applications in the UK, it appears that the MHRA is now in an ideal position to meet that aim. 

The analysis was performed by the MHRA and the University of Liverpool and published in the British Journal of Clinical Pharmacology. It provides a detailed overview of the current clinical trials landscape in the UK and, importantly, 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, it will be easier and faster to bring new medicines to patients (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 sits within 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. This includes the MHRA, the National Health Service, and the Health Technology Assessment (HTA) bodies. The scheme is expected to bring efficiencies in clinical trial recruitment and cut delays to study start.

Using the UK’s Unique Clinical Research Infrastructure

This sits alongside unique benefits of the UK clinical infrastructure, such as the UK Biobank and the Clinical Practice Research Datalink (CPRD). These provide access to anonymised patient data encompassing 60 million users of the National Health Service. 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. Whilst cancer trials currently represent most clinical trials, cutting-edge treatments, such as cell and gene therapies, represent a growing area. 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 drive advancement in this type of research.

What’s Next for Clinical Trials in the UK?

Understanding the clinical trials landscape is essential to getting medicines to patients efficiently. 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 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, helping to 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.