EMA
On 22 November 2017, a new and improved version of EudraVigilance will be launched by the European Medicines Agency (EMA).
Users of this system, including marketing authorization holders and sponsors of clinical trials, should prepare themselves to ensure that their procedures and local IT-infrastructures are compatible with the new system as well as with the internationally approved format. This improved version will be launched simultaneously with the implementation of the new legal obligations of reporting electronically via EudraVigilance, as announced by the EMA Management Board.
More information can be found at EMA’s website.