The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the MHRA is changing.
From 01 June 2024, ASRs such as the Development Safety Update Report (DSUR) will not be considered valid unless MAH provide proof of payment of the DSUR Review Fee with submission.
The payment associated with submission of annual safety reports to the MHRA will only be accepted via our online portal MHRA Pay.
A receipt generated via MHRA Pay will be sent by email upon completion of payment and must be included in the submission of the annual safety report as proof of payment.
The cover letter accompanying the submission must include:
- a listing of all the IRAS IDs and/or EudraCT numbers of trials covered by the annual safety report
- an email address for correspondence
- the submission reference number in the format: ‘DSUR-[5 digit MHRA company number]-[IMP name]-[Payment date DD/MM/YYYY]’
Ensure that those submitting Annual Safety Reports/ DSURs to the MHRA are aware of this requirement ahead of 01 June 2024, and review organisation’s processes for regulatory submissions to ensure this change has been incorporated.
A review of current clinical trial portfolio and DSUR submission due dates may be useful to identify which DSUR submissions will be affected by this change and require additional oversight to ensure their submission to the MHRA is valid.
Reference:
