EMA's Annual Report on the EudraVigilance Database

On 27 March 2019, the EMA published the Annual Report 2018 on the European database for the collection of adverse reactions to medicinal products, EudraVigilance. This annual report summarizes the current status of the database.

The EudraVigilance database is used for the Europe-wide registration and analysis of adverse reactions to medicinal products authorized within the EU. With a total number of over 14.5 million individual cases, the EudraVigilance database is one of the largest pharmacovigilance databases in the world.

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.