UK: MHRA Announces Combined Regulatory and Ethics Review Starting in 2022
On July 15, 2021, the United Kingdom’s (UK’s) Medicines and Healthcare products Regulatory Agency (MHRA) announced that starting in January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) will undergo combined review from the MHRA and the UK Research Ethics Services. Applicants will only need to submit one application and the clinical trial authorization and ethics approval will be delivered together.
MHRA is encouraging applicants to start using the combined review process now to ensure they are prepared for when it is required in January 2022. More information on combined review and how to get started is available here.
For details on all of the UK’s clinical research regulatory requirements, view the UK country profile on ClinRegs.