The UK’s Clinical Trials Regulation (CTR), signed into law in April 2025, aims to foster innovation, accelerate approvals, and enable patient participation in research while safeguarding their safety and rights.
Supporting innovation is a key priority for the Medicines and Healthcare products Regulatory Agency (MHRA), particularly as the UK has experienced a steady decline in trial initiations over the past eight years. This trend is concerning for several reasons:
- Fewer clinical trials reduce UK patients’ access to early, potentially life-changing treatments.
- The country risks losing the financial and scientific benefits of commercial research.
- Uptake of health innovations can be delayed or diminished.
Attracting and keeping innovation in the UK
To address this, the MHRA is focused on two goals: attracting overseas sponsors to initiate Phase 1 trials to the UK and encouraging UK-based innovators to run their studies domestically rather than defaulting to the US.
One way the UK is streamlining its regulatory process is through a combined regulatory and ethics review. The MHRA also plans to introduce tacit approval, a system familiar to US sponsors whereby trials can begin if the regulator raises no concerns within a fixed period. This is similar to the FDA’s 30-day IND review period. This shift will likely be welcomed by sponsors accustomed to faster, more predictable timelines.
As previously noted, the UK CTR bears a close resemblance to the EU CTR, easing the administrative burden for those navigating both jurisdictions. This alignment allows sponsors to obtain initial approval in the UK while their EU Clinical Trial Application is under review by the EMA. This strategic sequencing not only saves time but helps companies familiarise themselves with EU systems in a lower-friction setting.
Furthermore, by starting trials in the UK, sponsors can benefit from early MHRA feedback and input from ethics committees. This provides a valuable opportunity to refine their CTA based on regulator and ethics insights before engaging with EU authorities.
By prioritising the UK, sponsors can take advantage of the feedback from the MHRA, gather what the ethics committee has to say about their application, address any of those issues and polish their CTA before submitting it to the EMA.
Reclaiming the UK’s role as an innovation leader
The UK has long been recognised for its research excellence, with world-leading universities and a dynamic biotech ecosystem. According to the UK Bioindustry Association (BIA), the country’s biotech sector raised £3.5 billion in 2024 alone.
This environment has supported partnerships such as BioNTech’s collaboration with the NHA to deliver precision cancer immunotherapies to 10,000 UK patients by 2030. The UK government has further bolstered this initiative with a grant of up to £129 million to support new R&D facilities.
The new CTR is also aligned with ICH E6 (R3), introduced in January 2025, which promotes a risk-proportionate, quality-by-design approach to clinical trials. By incorporating these global principles, the UK strengthens its position as a forward-thinking regulatory environment, helping sponsors design robust, efficient and compliant trials.
By positioning the UK as a leader in the clinical trial space, the MHRA is demonstrating to the biopharma industry that the country is a leading destination for biomedical research. With its robust infrastructure, world-class research capabilities and collaborative regulatory environment, the UK is well-positioned reclaim its leadership in clinical research and potentially even be a global leader in the adoption of clinical trial standards.