The EudraVigilance database is used for the Europe-wide registration and analysis of adverse reactions to medicinal products authorized within the EU. EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.

With a total number of over 14.5 million individual cases, the EudraVigilance database is one of the largest pharmacovigilance databases in the world. EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has adopted the EudraVigilance operational plan from 2018 to 2020. EMA publishes data from EudraVigilance in the European database for suspected adverse drug reaction. EMA and national competent authorities are responsible for regularly reviewing and analysing EudraVigilance data to detect safety signals. The Pharmacovigilance Risk Assessment Committee (PRAC) evaluates the safety signals detected in EudraVigilance and may recommend regulatory action as a result.

EU take first steps

On 27 March 2019, the EMA published the Annual Report of 2018 on the European database for the collection of adverse reactions to medicinal products and EudraVigilance.

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.

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