The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled the next phase of its 2026 reform agenda to expedite clinical trial approvals. These measures – scheduled for implementation in April – follow a 9 per cent rise in trial applications during 2025. A new fast-track notification route will accommodate approximately 20 per cent of lower-risk studies. This allows sponsors to start research sooner while experts prioritise more complex applications.
Dr Zubir Ahmed, Health Innovation Minister at the Department of Health and Social Care (DHSC), confirmed that the government is focused on reducing set-up times. A dedicated 14-day assessment pathway for phase 1 trials will restore rapid testing for new medicines in human participants. This shift aligns with the 10 Year Health Plan for England to modernise the national research infrastructure.
Lawrence Tallon, Chief Executive of the MHRA, stated that sponsors require speed, clarity, and flexibility. The agency is enhancing its capabilities to include the assessment of computer model simulations – such as in-silico trials – and the integration of early safety data from overseas jurisdictions. These reforms build on existing performance gains, where the MHRA reviewed 99 per cent of applications within statutory timelines last year.
Professor Lucy Chappell, Chief Scientific Adviser at the DHSC and Chief Executive Officer of the National Institute for Health and Care Research (NIHR), noted that predictable timelines encourage international investment. Data from the MHRA show that early-phase research – particularly trials involving healthy volunteers – grew by 16 per cent in 2025. The reforms aim to reduce the time from application to the first participant to 150 days. These changes remove administrative bottlenecks and simplify the pathway for high-quality clinical research.
Source: Medicines and Healthcare products Regulatory Agency
Link: Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation
Date: 13 January 2026
