EMA Reports Jump in Adverse-Event Reporting in 2013

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-30-2014 10:55


The European Medicines Agency (EMA) reported that its web-based information system, EudraVigilance, received more than one million post-marketing expedited adverse-drug-reaction (ADR) reports, according to the second annual report on EudraVigilance for the European Parliament, the Council and the Commission. The report, covering the period from January 1 to December 31, 2013, shows a 26% increase in expedited ADR reports over 2012, resulting in the highest ever annual figure. The greatest increase occurred within the European Union (EU), showing the combined effort of the EU medicines regulatory network to encourage reporting to of suspected adverse reactions to medicines.

The most notable increase was in adverse reactions reported by patients within the European Economic Area, which was 52% higher than in 2012. This is due to increased awareness among the general public of the importance of adverse reaction reporting, resulting in part from the new EU pharmacovigilance legislation, which introduced direct reporting of adverse reactions by patients and consumers in all Member States.

EudraVigilance is a web-based information system that collects, manages, and analyses reports of suspected side effects of medicines.The data held in the database is used for continuous safety monitoring of medicines by EMA and the member states of the EU.

The reports received in 2013 were processed and subsequently made available for signal detection and data analysis by the EMA and medicines regulatory authorities in the EU member states, which subsequently took appropriate regulatory action when necessary. In 2013, the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) prioritized and assessed 100 signals, including 43 detected and validated by the EMA and 57 by EU member states.

Source: EMA


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