Special Edition: International Clinical Trials Day
Firstly, I want to say thank you for the warm welcome since I joined the MHRA as Chief Executive in April.
But those days are firmly behind us, and I want to send a clear message: we are fully committed to creating a dynamic, world-leading environment for clinical trials that delivers real innovation and better health outcomes for patients.
Last year, we assessed over 5,000 clinical trial applications. Since September 2023, we’ve handled 100% of applications within statutory timeframes. Our Combined Reviews with the Health Research Authority are now being completed in just 40 days on average—20 days faster than the 60-day timeline.
But we are not stopping there. Last month marked the beginning of the most significant overhaul of clinical trial regulation in over 20 years, setting the stage for a faster, more flexible, and more proportionate regulatory system that supports cutting-edge research and speeds up access to transformative treatments.
I am energised by the momentum we’re building with industry. I’ve met with trade associations and leaders from across the life sciences sector, and I’ve been struck by our shared ambition to make the UK a place where innovation flourishes and where NHS patients see the benefits faster than ever before. I’m excited to work with you to make this vision a reality.
To find out more, the full reflections of our CEO Lawrence Tallon on International Clinical Trials Day can be found here.
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“…the MHRA is once again taking a global lead” says Lord O’Shaughnessy
Major progress has been made in delivering a more efficient and adaptable regulatory framework for clinical trials, the Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) has reflected on International Clinical Trials Day.
New regulations – which represent the most significant update to the UK clinical trials landscape in 20 years – are designed to put participants firmly at the centre of how trials are run, while supporting faster, more streamlined approvals, making it easier to test new treatments in the UK.
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In a new interview with The Pharma Letter, Professor Andrea Manfrin, MHRA Deputy Director of Clinical Investigations and Trials, explains how the agency is building a faster, smarter, and more resilient clinical trials framework. “The fact that one in eight trials conducted in the UK are first in human shows we are already a research powerhouse. But our new regulations, which will come into force in April 2026, will make the UK an even more attractive place for innovators to conduct important research by being more risk-proportionate and streamlined.” Read the full Pharma Letter interview: MHRA what we're doing to cement the UK's position as a world leader in clinical research | The Pharmaletter
We have launched a consultation to seek feedback on a draft guideline to support sponsors who are considering the use of real-world data in external control arms in clinical trials for new medicines and medical devices.
The consultation is open until Monday 30 June 2025 and anyone interested in clinical trials in the UK is invited to respond.
The guideline includes points to consider when planning a clinical trial that will include a real-world data external control arm, when there is an intention to submit that trial for regulatory approval.
The guideline has been drafted with input from the Commission for Human Medicines’ real-world data group and complements existing guidance we previously sought views on. It is an example of the MHRA’s support for innovation in clinical trials and our drive to ensure the UK remains one of the best places in the world for clinical research.
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Finally, Professor Andrea Manfrin, MHRA Deputy Director of Clinical Investigations and Trials speaks to Pink Sheet about Combined Reviews, the Notification Scheme and increasing Diversity. Read the full piece here: UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity
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