Clinical trial regulation is changing for the better
We’ve been working with the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health Research (NIHR) as well as our partners in the devolved administrations, to provide a more streamlined and efficient service for new drug trials.
Our combined review brings together a single Clinical Trials of Investigational Medicinal Products (CTIMP) application for both Clinical Trial Authorisation and Research Ethics Committee (REC) opinion. Already benefiting sponsors, contract research organisations and researchers, as of 1 January 2022 this service is the way all new CTIMP applications will be made.
Combined review enhances the UK’s reputation as an attractive option for ground-breaking research that has the potential to improve health and wellbeing, facilitating rapid start-up to benefit patients sooner.
Advice for CTIMP sponsors and researchers
Combined review should now be used for all new CTIMP and combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials). If you are a CTIMP sponsor or applicant we have the information, guidance and support to help you prepare for change.