On 27 March 2019, the Annual Report 2018 on the European database for the collection of adverse reactions to medicinal products, Eudravigilance, was published by the EMA. It’s a summary of the current status of the database.
EudraVigilance is used to registrate and analyse adverse reactions to medicinal products authorized within the EU. The database is one of the largest databases in the world with a total number of over 14.5 million individual cases.
Over 2 million adverse drug reactions were reported in 2018. This 37%-increase is largely due to the requirement that, since November 2017, national authorities and Marketing Authorization Holders (MAHs) have been obliged to also report non-serious adverse reactions to EudraVigilance. Based on the evaluation of reported cases, the Pharmacovigilance Risk Assessment Committee (PRAC) evaluated 114 signals (39% more than in 2017) of which 50 (44%) resulted in recommended changes to product information and 6 were accompanied by DHPC (Direct Healthcare Professional Communication) as an additional risk-minimizing measure.
More details about enhanced functionalities, data quality and information about EudraVigilance developments are summarized in the EMA’s Annual Report.