On August 31, 2021, MHRA launched new systems functionality to support the combined review of Clinical Trials of Investigational Medicinal Products (CTIMPs). The combined review service (previously known as ‘combined ways of working’) offers a single application submission route and a coordinated review for CTIMPs, resulting in a combined regulatory and ethics decision on a clinical trial.
The trial sponsors can now manage their complete trial lifecycle via combined review using the Integrated Research Application System (IRAS) – from initial application through to amendments, safety reporting, end of trial notification and submission of summary results. From January 01, 2022, the combined review will become the only way to apply for CTIMP approvals.