UK CTA: What Lies Ahead for 2025?

The current UK Clinical Trials Statutory Instrument has been in force since 2004 and has been in need of updating for a while. An updated Clinical Trial Statutory Instrument (SI) was laid before the UK parliament in Dec 2024.  Following government approval of the updated SI, MHRA envisage a 12 month transition period anticipating that the SI would come into force in early 2026.  The SI aims to streamline and simplify the clinical trial environment in the UK and to embed existing elements of the UK Clinical Trial regulatory framework such as combined MHRA and REC review.  But what other changes will the approved SI bring and what are the implications for developers? 

The updated SI includes details around the new clinical trial framework; for example the concept of Type A and Type B substantial modifications to CTA applications.  Type A modifications would be reviewed and approved in the usual way by MHRA.  For Type B modifications, ones that meet specific criteria, the need for review by MHRA would be waived.  Type B modifications are those for example that have already been reviewed and approved by the EU or US Health Authorities.  Another change is the introduction of a clinical trial notification, for trials that meet certain criteria MHRA would offer an expedited review timeframe.  Other changes include embedding the requirement for clinical trial transparency in UK law and a pilot program that invites developers to submit inclusion and diversity plans to MHRA on a voluntary basis. 

The UK Clinical Trial framework is rapidly evolving and 2025 will likely see the issue of many new guidance documents. If you have questions or face challenges with your clinical trial development, tranScrip regulatory and clinical experts are at the ready to guide and advise you; we are ready to expedite your development programs and bring effective medicines to patients across the UK and beyond.