Drug makers and clinical trial sponsors operating in the EU should by now have ensured they are set up to use the test environment for the enhanced EudraVigilance database for managing and analyzing suspected adverse reactions to authorized medicines, which will go live on Nov. 22.
The test system, XCOMP, was launched by the European Medicines Agency on June 26. Marketing authorization holders (MAHs) and trial sponsors should have made sure their technical experts were registered to access the XCOMP environment by the June launch date, according to a