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Guidance on submitting clinical trial safety reports from 1 January 2021

Guidance on submitting clinical trial safety reports from 1 January 2021
December 22, 2020 SueCarr

Following the end of the transition period, SUSARs in GB and in Northern Ireland are reported to the MHRA using either the eSUSAR website, the ICSR Submissions pathway or using the MHRA Gateway, which replaces the Eudravigilance Gateway. If one of the new reporting routes is being used, Sponsors or other reporting parties must register with the MHRA as soon as possible.

Read more here.