In a recent report, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the time taken to approve clinical trials has been reduced from 91 days to just 41 days in the UK. This reform is a part of a wider goal to reduce clinical trial set-up times to 150 days and modernise research through the 10 Year Health Plan.
The Clinical Trial Application review is typically time consuming as regulatory authorities need to decide whether the clinical trial is safe, valid and ethical enough to give it the ‘green light’ and proceed to the next stages. The trial preparation after approval can take several more months, making it a highly labour-intensive process. Although there are fast-track options for some clinical trials, a longer wait time for many trials is normally expected.
The new reform to reduce the approval process to 41 days is anticipated to help speed up the initial application. UK Health Minister Stephen Kinnock said this decision was made to help streamline processes so that NHS patients ‘receive life-changing treatments faster than ever before.’ Furthermore, digital dashboards are also used to track applications in real-time which will help improve time management.
The findings were published in early October 2025 in the British Journal of Clinical Pharmacology (BJCP), following analysis conducted by the MHRA, in collaboration with the University of Liverpool, of more than 4,600 clinical trials initial applications and amendments in the first year of the MHRA’s risk proportionate approach, launched with patient input in August 2023. Professor Sir Munir Pirmohamed, co-author of the study at the University of Liverpool, said that: ‘99% of clinical trial applications are being completed within the statutory timelines’, indicating that the majority of clinical trial applications are meeting targeted timeframes.
New legislation that applies to this reform is expected to come into force in April 2026.
