The Danish Medicines Agency can now receive electronic reports of suspected unexpected serious adverse reactions, also known as SUSARs, from trials in other EU countries.
SUSARs that occur in other EU/EEA countries must be reported to the Danish Medicines Agency if the trials have the same protocol (EudraCT number) as in Denmark. The new opportunity of electronic submission applies to precisely these SUSARs.
It makes work easier for those pharmaceutical companies which already report SUSARs electronically that all SUSARs can be reported to the Danish Medicines Agency via E2B
Before, these SUSARs were to be submitted on paper.
Read our updated announcement on the reporting of adverse reactions in clinical trials via the link in the right-hand box.