The countdown is on to 1 January 2022, when combined review with the Medicines and Healthcare products Regulatory Agency (MHRA) becomes the way all Clinical Trials of Investigational Medicinal Products (CTIMPs) applications are made. Over the coming weeks we’ll make sure that applicants, sponsors and host sites are fully prepared for the changes.
From 30 November, CTIMP applicants and sponsors submitting via combined review will benefit from a wider choice of Research Ethics Committee (REC) meeting dates in new IRAS.
Combined review should now be used for all new CTIMP and combined IMP/device trials. If you’re preparing applications in the standard part of IRAS, these should be submitted by 31 December 2021. If you have any queries, please contact our team at cwow@hra.nhs.uk.
Our web pages will be kept updated with the latest information, guidance and Q&A. If you are an applicant, sponsor or host CTIMP studies at your site, you can also book onto one of our IRAS business change webinars during December and January.