Writing in the September 2025 edition of DIA’s Global Forum magazine, Janet Messer, Catherine Blewett, and Naho Yamazaki of the UK Health Research Authority (HRA) and Stephen Lam, Crina Cacou, Anthony Carter, and Sara Rajendran of the UK Medicines and Healthcare products Regulatory Agency (MHRA), lay out how UK clinical research regulation should evolve for the better.

 

The UK is committed to creating a modern, streamlined regulatory environment for clinical research that upholds the highest standards of participant safety while accelerating access to innovative treatments. At the heart of this transformation is a collaborative, digitally enabled approach that supports efficient, proportionate, and patient-centered clinical research.

This article is the start of a series that describes the challenging journey of a clinical trial regulation system that had, due to the UK’s exit from the EU, the opportunity to reinvent itself, taking past learnings to create the best possible system of the future, achieving an average 41-day clinical trial application review time.

 

A Foundation for Reform

The Medicines and Healthcare products Regulatory Agency (MHRA) was formed in 2003 by integrating the existing medicines and devices regulators. The MHRA authorizes clinical trials and oversees their conduct.

The other key regulatory process for clinical trials is ethics committee review. The Health Research Authority (HRA) coordinates the UK’s research ethics committees. It was established following the 2011 Academy of Medical Sciences report, A new pathway for the regulation and governance of health research. This report highlighted the burdensome UK research regulatory landscape and called for a unified, risk-proportionate framework. The Care Act 2014 brought this vision to life, not only establishing the HRA but also mandating cooperation among UK regulatory bodies to standardize proportionate research regulation. The UK’s central coordination of research ethics committees and the cooperation with the MHRA create a unique foundation for clinical research. Both agencies are public bodies sponsored by the UK Department of Health and Social Care.

This statutory duty to cooperate underpins the UK’s approach to clinical trials. The Integrated Research Application System (IRAS) exemplifies this. As described in the accompanying series article in this issue, we are now collaborating on new developments to deliver digital services that span the end-to-end journey to plan, approve, set up, manage, and complete research.

 

Streamlining Through Partnership

One major outcome of the MHRA-HRA partnership is the combined review service for clinical trials of investigational medicinal products (IMP), developed by the MHRA and the UK Research Ethics Committees (REC). Piloted in 2018 and fully launched in 2022, it provides a single application route and coordinated review, reducing timelines and avoiding conflicting requirements. Piloting the process and new technology involved commercial and noncommercial sponsors as well as contract research organizations (CROs) working together to refine the process. In 2025, the total average time to determine an initial Clinical Trial Authorisation (CTA) from application received, including the response to questions raised, to authorization for the trial and ethics approval via the combined review process was under 41 days.

 

Read the full article on the DIA Global Forum website here