New EudraVigilance system improves reporting of side effects and detection of safety signals

EMA

27 March 2019 - The new and improved EudraVigilance, the European system for managing and analysing information on suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the EU, received more than 2 million reports of suspected side effects in 2018. 

This is an increase of 37% compared to 2017 which largely reflects that from November 2017 the national competent authorities and the marketing authorisation holders were required to report non-serious cases of suspected adverse reactions to EudraVigilance, having previously only reported serious cases.

This was also a key driver for the increase in the number of reports received from European patients and consumers through national authorities and marketing authorisation holders, which almost doubled between 2017 and 2018. Improvements in patient reporting also reflect efforts at national level to encourage patients to share information on side effects through information campaigns. These and other findings are summarised in EMA’s annual report on Eudravigilance published today.

Read EMA press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , Europe , Regulation , Safety