Words by Jade Williams
The UK government has formally signed into law new clinical trial regulations, designed to modernise operations across the country. These changes mark the most substantial reform in two decades and will be phased into effect over a 12-month period.
Key objectives of the changes include improving patient safety, accelerating trial approvals, reducing operational burden and fostering innovation – all with the aim of reinforcing the UK’s appeal as a global hub for clinical research.
“These new regulations are a key step towards a stronger, more responsive and risk-proportionate clinical trials system that works better for patients,” commented Lawrence Tallon, Chief Executive, MHRA. “They will help ensure people in the UK can benefit sooner from safe, carefully assessed research into new potentially life-saving medicines, while maintaining the highest standards of participant safety.”
New provisions aim to eliminate duplication, reduce regulatory burden for lower-risk trials and create a more supportive environment for global sponsors conducting research in the UK.
Additionally, a Combined Review system, allowing researchers to apply for ethics and regulatory approval in one step, along with a streamlined notification scheme for certain clinical trial applications and amendments, will be formally written into law.
Janet Messer, Director of Approvals Service, Health Research Authority (HRA), explained: “These changes reflect our commitment to making it easier to conduct high-quality research that people can trust.” She went on to say: “We’ve worked closely with patients, researchers and partners across the system to ensure the new regulations protect participants while reducing unnecessary burden.”
As the implementation period begins, the HRA is working with the MHRA and partners to help sponsors and researchers prepare. Support will include new guidance, training events and opportunities to shape transparency measures.
