New clinical trials regulations laid in parliament (HRA and MHRA, 12 December 2024)

Summary

The laws which regulate the way clinical trials are carried out in the UK are changing. The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been working for the past two years to draft proposals to update clinical trials regulations. The updated regulations will be debated in the new year and after a 12 month implementation period will come into force in early 2026.

Updating this law started in 2022 with a public consultation which asked for feedback on how the regulation of clinical trials could be improved and strengthened in the UK. The statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 was laid before Parliament on 12 December 2024. This article explains the changes to the regulations which aim to create a faster, more efficient, more accessible and more innovative clinical research system in the UK.