New UK Clinical Trials Regulations Laid in Parliament After 20 Years

The reforms follow a public consultation held from January to March 2022, which received more than 2,000 responses, and a government response published in March 2023.

What the new clinical trials regulations change

The legislation removes duplicative requirements and streamlines processes, embedding in law the combined review of regulatory and ethics assessments and a notification scheme for some initial applications and amendments. The MHRA said the reforms take a risk-based approach and are designed to let sponsors work across countries, so that the UK remains a preferred site for multinational trials.

When the overhaul was announced in March 2023, the MHRA said the framework would also introduce a legal requirement to register trials in a World Health Organization public register and to publish a summary of results within 12 months of the end of a trial, and would require findings to be shared with participants. It noted that combined review had, in its pilot phase, halved approval times for studies.

Who is affected

Pharmaceutical and biotech sponsors, contract research organisations, NHS trusts and academic researchers running interventional trials of medicines in the UK will all need to adapt. The MHRA and the Health Research Authority are also producing guidance to embed meaningful public involvement and increase the diversity of trial participants.

What happens next

Guidance will be developed with stakeholders and published during the implementation period. Sponsors should use that time to update standard operating procedures, transparency processes and contracts with sites and vendors so that they are ready when the new clinical trials regulations take effect.

Sources

• GOV.UK (MHRA): New clinical trials framework being laid in Parliament today
• GOV.UK (MHRA): MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years