The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events.

In the lead up to the launch of the new EudraVigilance system, EMA says national competent authorities, marketing authorization holders (MAHs) and sponsors of clinical trials have to make final preparations to ensure that their processes and IT infrastructures can work with the new system.

Background

First launched in 2001, EudraVigilance is a database for reporting and evaluating suspected adverse drug events during the development, and following the marketing authorization of drugs in the European Economic Area (EEA).

In 2010, EMA’s management board adopted a EudraVigilance Access Policy, which came into force in July 2011 and outlined the data elements for and instructions on how to access Individual Case Safety Reports (ICSRs) from EudraVigilance for drug regulators, health professionals, patients and consumers, MAHs in the EEA and research organizations.

Revamped System

Among the benefits of the new system cited by EMA:

• MAHs will no longer have to provide ICSRs to national authorities, but will provide them directly to EudraVigilance, which will likely reduce duplicative efforts;
• Increased transparency and more access, including enhanced search options, to suspected adverse events by health professionals and the public;
• More efficient collaboration with the World Health Organization (WHO) as EMA will make ICSRs available to the WHO Uppsala Monitoring Centre directly from EudraVigilance, meaning member states will no longer need to carry out this task.

In preparation for the new system, EMA said it will support national competent authorities, MAHs and sponsors of clinical trials in the EEA through targeted e-learning and face-to-face trainings, webinars and information days. Users can trial the new functions of the EudraVigilance system and the internationally agreed format for ICSRs in a test environment as of 26 June 2017.

"The reporting of adverse reactions by patients and healthcare professionals to national competent authorities based on local spontaneous reporting systems will remain unchanged," EMA added. "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."

Further information is available on the EudraVigilance training and support webpage.

Announcement of the EMA Management Board Confirmation of full functionality of the EudraVigilance database

Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions