MHRA – The UK changes SUSAR Reporting for IMPs (Gene and Cell Catapult Regulatory Round-up – September 2022)
The MHRA has now retired the eSUSAR website in favour of Individual Case Safety Reports (ICSR) Submissions, providing users “a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational Medicinal Products” (IMPs).
The eSUSAR website used for the submission of SUSAR reports to the MHRA was decommissioned at the end of September 2022 and only SUSARS via the ICSR Submissions portal will be acceptable from 1 October 2022.
Read more in the MHRA Inspectorate blog Decommission of eSUSAR.
See all of the Gene and Cell Catapult’s regulatory round-up for september 2022 here. Published on the 4th of October 2022.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (30 novembre 2022). MHRA – The UK changes SUSAR Reporting for IMPs (Gene and Cell Catapult Regulatory Round-up – September 2022). ELSIBI. Consulté le 10 décembre 2024 à l’adresse https://doi.org/10.58079/o65l
