The EMA has launched a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic Area (EEA). The new system makes it easier for marketing authorization holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe.
The enhancements and expected benefits of the new EudraVigilance are:
Together with the launch, further legal obligations will become applicable to the mandatory electronic reporting through EudraVigilance, as stated in the announcement of the EMA Management Board published in May.
The reporting of adverse reactions by patients and healthcare professionals to national competent authorities based on local spontaneous reporting systems will remain unchanged. There will also be no changes to the reporting of suspected unexpected serious adverse reactions during clinical trials until the application of the new Clinical Trial Regulation. Public access to data held in EudraVigilance will be provided through the adrreports.eu portal, which includes new features for data retrieval and representation.
The Agency will continue to support national competent authorities, marketing authorization holders and sponsors of clinical trials in the EEA through targeted e-learning and face-to-face trainings, webinars and information days.