How to avoid delays when submitting clinical trial application assessments

The UK’s new clinical trial regulations came into force on 28 April 2026, introducing a more flexible and risk-proportionate approach to clinical trial assessment. Sponsors now submit a single clinical trial application for review by both the MHRA and a Research Ethics Committee (REC) through the Integrated Research Application System (IRAS). The aim is simple: to help potentially life-changing medicines to reach patients faster, while maintaining the highest standards of safety and oversight.

 

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