Almac has published a new podcast exploring the UK Clinical Trial Update, with a focus on the revised enforcement provisions. The changes, set to take effect in April 2026, introduce a more structured and transparent approach to the regulator's management of non-compliance.
The updated framework expands the range of enforcement tools available to the MHRA, including infringement notices and new offences related to safety reporting and transparency. While the approach remains proportionate, there is a clear expectation of increased compliance from sponsors and investigators.
In the podcast, Almac discusses what these changes mean in practice and how organisations can prepare for the new regulatory environment.
Listen to the podcast here.