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.
According to the report, EMA reviewed more than 2,200 potential signals. This is information on a new adverse reaction or new aspect of a known adverse reaction that is potentially caused by a medicine and warrants further investigation. Almost 80% of these signals originated from monitoring the EudraVigilancedatabase. Other signals were generated from clinical studies and scientific literature.
The Agency’s safety committee (PRAC) assessed 114 safety signals in 2018, 40% more than in 2017. 44% of the signals assessed by PRAC resulted directly in a recommendation to change the product information for patients and healthcare professionals, thus ensuring the safe and effective use of medicines.
Both EMA and national competent authorities are required by legislation to continuously monitor the adverse drug reaction data reported to EudraVigilance to determine whether there are new or changed risks and whether they have an impact on a medicine’s overall benefit-risk balance. With over 14.5 million individual case safety reports in total, Eudravigilance is one of the largest pharmacovigilance databases in the world and a powerful tool for regulators in the EU to monitor the safety of medicines.
EudraVigilance also provides data directly to the World Health Organization (WHO) Uppsala Monitoring Centre. With more than 1 million individual case safety reports forwarded to WHO in 2018, EudraVigilance makes a significant contribution to protecting public health worldwide.
An improved version of the EudraVigilance system in November 2017 simplified the reporting of suspected adverse reactions, enabled better analysis of data for the benefit of patient safety in Europe and increased the transparency and accessibility of these case reports.