New clinical trial reforms aim to speed up access to treatments
New clinical trial regulations have come into force across the UK from 28 April 2026, introducing the most significant reforms to the system in over 20 years. The changes are being implemented by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA).
The reforms are designed to reduce set‑up times for clinical trials, particularly for lower‑risk studies, while maintaining participant safety. Key measures include faster assessment of first‑in‑human trials, a new notifiable trials pathway allowing some studies to start more quickly, and streamlined approval of trial modifications.
According to the regulators, these changes have already contributed to a reduction in average trial set‑up times, from 169 days to 122 days for studies using combined safety and ethics review.
The new framework also introduces mandatory trial registration and publication of summary results, with the aim of improving transparency and supporting more efficient delivery of clinical research in the UK.
Read the full press release here: Launch of clinical trial reforms – GOV.UK
