he 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.

Clinical Research as an Integral Part of the UK Health System

The UK Clinical Research Delivery (UKCRD) program is a cross-sector initiative focused on creating a faster, more efficient, more accessible research delivery system in the National Health Service (NHS). Whilst the clinical trial regulatory review timelines are competitive at 41 days, the time to set up clinical trials in the NHS is lagging compared with site setup in other countries. The aim is to cut clinical trial setup times from regulatory submission to first participant to under 150 days. The program aims to streamline processes by removing contract negotiations, standardizing costs, and reducing duplication across NHS sites.

Agility in the Face of Crisis

The UK’s regulatory agility was proven during the COVID-19 pandemic. Pre-existing guidance on risk-based monitoring, direct-to-patient shipment of IMP, and electronic consent, though underutilized before the pandemic, became essential tools for rapid trial deployment. These flexibilities, grounded in MHRA guidance dating back to 2011 and the 2012 GCP Guide, enabled swift adaptation without compromising safety or integrity.

Despite this, uptake of risk-adapted approaches by sponsors remained cautious. To address this, the UK has embedded these principles into the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, effective April 2026. These changes align with the latest International Council for Harmonisation (ICH) E6 guidance and provide a clear legal foundation for proportionate trial conduct. Certain CTA applications and modifications will now receive automatic approval from the licensing authority if specific criteria are met. Co-created guidance is underpinning the implementation of these improvements.

Enabling Decentralized Research

The new legislation also supports decentralized trial models. Updated guidance clarifies how investigators can oversee activities remotely, and the removal of references to fixed trial sites in the legislation empowers sponsors to design studies around participants’ needs.

Advancing Diversity and Inclusion

Recognizing the importance of representative research beyond the regulations, the UK is strengthening its guidance on inclusion and diversity. A new template helps researchers consider how to include populations most likely to benefit from study outcomes. Expectations for public involvement in trial design are also being updated, with specific recommendations for phase 1 healthy volunteer trials.

New tools will provide sponsors with data on prevalence, ethnicity, and socioeconomic factors, alongside data on relevant research experience for the health and care providers in those locations.

Supporting Innovation in Manufacturing

In July 2025, the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations enabled decentralized manufacturing of IMP. This supports the UK’s ambition to be a global leader in innovative trial delivery.

Timelines Reform: Fixed to Flexible

Current regulations set different statutory timelines for MHRA and REC decisions. The consultation on the new clinical trial regulations demonstrated a clear call from sponsors—particularly those conducting global trials—for coordinated assessment times and flexibility in the time to respond to a request for further information. The new regulations align these: 30 days for initial review, 10 days for the response to any further information. Sponsors can choose their response speed, with extensions beyond 60 days allowed with justification. These new timelines aim to achieve competitive performance from the regulators whilst allowing flexibility in timelines for sponsors coordinating global trials.

Call to Collaborate

UK regulators encourage sponsors to engage early using the Innovative Licensing and Access Pathway or by directly sending a query to the HRA or MHRA. What seems novel to one organization may be familiar territory for others. By working together, we can harness new technologies and trial designs to deliver faster, more efficient, and more inclusive research—without compromising safety or public trust. Learn more about implementation from the HRA website.