The MHRA Inspectorate has issued a formal notification that the transition to the Medicines for Human Use (Clinical Trials) (Amendment) (No. 2) Regulations 2024 is now in its final six months. This update follows an extensive public consultation held in 2022 and represents the first major change to the UK’s trial framework since 2004. The new rules, which come into full effect on 28 April 2026, aim to streamline the approval process and ensure the UK remains a leading destination for international research.
A central feature of the announcement is the shift from a pilot phase to a legal requirement for the "combined review" process. Under the previous 2004 system, sponsors often dealt with the regulator and ethics committees separately. The new statutory framework mandates a single application via the Integrated Research Application System, resulting in a joint decision from the MHRA and the Research Ethics Committee. This change is designed to remove administrative hurdles and speed up the time it takes to start a trial.
Transparency requirements have also been strengthened. Data are now subject to stricter public disclosure rules; trial details must be entered into a recognised registry before the first participant is recruited. Furthermore, a summary of trial results must be published within 12 months of the trial's conclusion. The regulations also introduce a "risk-proportionate" approach for trials involving authorised medicines where the risk is low, allowing for simpler notification processes rather than full applications.
Next steps for those managing trial portfolios include an urgent review of internal training and operating procedures to align with these legal shifts. For those tasked with managing the transition from clinical evidence to patient availability, these reforms provide a more predictable and faster route for generating the evidence needed for market entry. The streamlined notification and approval paths will reduce the time taken to gather the necessary data, allowing for earlier assessment and potentially quicker patient reach.
Source: Clinical trials regulations – six month countdown begins
Date: 28 October 2025
