The HRA and the Medicines and Healthcare products Regulatory Agency (MHRA) have worked with the research community to develop a faster and more efficient service for the approval of clinical trials.
Historically, applications for clinical trials were sent separately to the MHRA for regulatory review, and to a Research Ethics Committee (REC) for ethics review. Now, with combined review, research teams make a single Clinical Trials of Investigational Medicinal Products (CTIMP) application, which goes to both reviews at the same time. This is reducing duplication, saving applicants time and effort, and speeding up approval timelines. Find out more about the benefits for CTIMP sponsors, contract research organisations (CROs) and investigators below.
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.
The benefits for research teams
- a single application for Clinical Trial Authorisation and Research Ethics Committee (REC) opinion
- a co-ordinated review process that ensures REC and MHRA outcomes are consistent and aligned
- combined requests for further information; a single response to queries leads to a single decision from both reviews
- the same simplified application and review process for any subsequent substantial amendments to the trial authorisation
- improved access to the NIHR Clinical Research Network (CRN)’s Study Support Service for researchers, with the opportunity to apply for support earlier and receive an eligibility decision sooner through the CRN’s Non-commercial Portfolio Application service
Advice for research teams
Combined review is now 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 information, guidance and support to help you.