Tag Archives: ASPRs

MHRA no longer sending ASPRs from literature to MAHs

The MHRA are no longer sending out Anonymised Single Patient Reports (ASPRs)/ Individual Case Safety Reports (ICSRs) from literature to Marketing Authorisation Holders (MAHs). This came about after a review by the BROMI Vigilance Workstream and should increase efficiency for both the MHRA and MAH Pharmacovigilance systems.  The MHRA state that the number of ASPRs sent out to companies could be reduced by 33-50%. This will be of particular interest to generic companies that hold numerous Marketing Authorisations in the UK.

The MHRA have published information about this which can be found by following the link below. It is important to continue reporting serious cases from literature in line with the MHRA’s instructions & Volume 9a to ensure continued compliance. If you have any questions about ASPRs and how to manage them, please contact us and we will be happy to help you.