Impact of HRA/MHRA’s combined review service on CTIMPs applying for NIHR CRN support
Date: 30 June 2021
The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA)’s combined review service, formerly known as Combined Ways of Working (CWoW), is expanding. This service streamlines the approval and management of clinical trials of investigational medicinal products (CTIMPs) through a single application and integrated review and outcome. As the combined review service will become the way that all CTIMP applications are submitted from 1 January 2022, the HRA and MHRA are encouraging a wider number of sponsor organisations to participate now and start experiencing the benefits it offers.
Studies applying via this route use new functionality within the HRA’s IRAS system and are not automatically received by the NIHR Clinical Research Network (CRN) for consideration for support. Instead, the CRN has been working with the HRA and MHRA to develop an improved process where study teams can apply for CRN support much earlier, and do not need to wait until IRAS submission – through a new Non-commercial Portfolio Application service available in CPMS. This enables study teams using the combined review to apply for CRN support directly through CPMS. Find out more here.