The MHRA regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health.
If your study is a clinical trial of a medicinal product, you’re required to obtain a Clinical Trial Authorisation (CTA) from the Medicines and Healthcare products Regulatory Authority (MHRA) before the research can start, via IRAS.
If your study is a clinical investigation or other study of a medical device, you may need to notify the MHRA and obtain a letter of no objection before you can carry out your study. Please see the MHRA website for information on how to notify the MHRA of your clinical investigation.