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On 22 November 2017, the European Medicine Agency (EMA) launched a new version of EudraVigilance, the European platform for the management of drug suspected adverse reaction reports within the European Economic Area (EEA).

The goal of this important updated is to improve reporting and analysis of suspected adverse reactions to increase the monitoring of medicinal products and make the reporting process more efficient by all concerned parties.

This has led to several changes in the management of adverse reaction reports, including:

  • mandatory transmission of adverse reaction reports directly to Eudravigilance by Marketing Authorisation (MA) holders of drugs;
  • changes to the National Pharmacovigilance Network to make it more compatible with the European system;
  • introduction of a re-routing system allowing data flow between Competent Authorities and EudraVigilance, in order to ensure completeness to both national and European databases.

Di Renzo Regulatory Affairs has a special unit dedicated to pharmacovigilance, with several experts taking daily care of the screening of Eudravigilance adverse reaction reports and of the single case management.