To mark International Clinical Trial Day (20th May), the Medicines and Healthcare products Regulatory Agency (MHRA) has announced new regulations to modernise the UK’s clinical trials framework, which is the most significant update in two decades.

The new regulations were developed with the Health Research Authority (HRA) as well as feedback from patients, researchers, clinicians, and industry, and are set to come into effect in April 226 following a 12-month implementation period.

These reforms intend to streamline clinical trial approvals and pivot the system to being more participant-focused. The MHRA has already improved standard operations, with 100 per cent of clinical trial applications processed within statutory timelines since September 2023.

By March 2024, the average time for Combined Review determinations was just 40 days, and all approvals were completed within 60 days.

Alongside this, the MHRA and HRA have also launched a pilot Inclusion and Diversity Plan, which has been informed by over 300 researchers to provide practical guidance to help sponsors design trials that better reflect the populations they serve.

Lawrence Tallon, chief executive of the MHRA, said: “I’ve experienced first-hand the life-changing impact clinical research can have on patients and their families. This, combined with the benefits it brings to the economy, is why it’s so important we ensure the UK is one of the most attractive places in the world to conduct trials.

“The UK is already a research powerhouse driven by innovation, with one in eight trials in the UK testing treatments in humans for the first time.

“But we want to go further. Last month, we began implementing the most significant update to UK clinical trials regulation in over two decades. These reforms will address the research sector’s need for a more risk-proportionate regulatory framework for clinical trials and will help get cutting-edge new treatments to the NHS as quickly as possible.”