MHRA

How do I know if my study requires approval from the Medicines and Healthcare products Regulatory Agency (MHRA)?

In order to assess whether a medicine(s) in use on a study falls in the category of an IMP and therefore would require a Clinical Trial Authorisation (CTA), the MHRA has produced a 5-step algorithm which can be found on pages 8-9 in a document on the MHRA website.

If you have any doubts about the answer to any of the questions contact the Clinical Trials Unit at the MHRA.

For general enquiries: clintrialhelpline@mhra.gsi.gov.uk or 020 7084 2456 (Monday - Friday 08:30-16:30)

For enquiries regarding documents and submissions: RIS.CT@mhra.gsi.gov.uk

For enquiries on fees: cashiers@mhra.gsi.gov.uk or 020 7084 2524