EMA Officially Endorses the New EudraVigilance System for Adverse Reactions

On May 22, 2017, the European Medicines Agency’s (EMA) management board endorsed the start of the official countdown for the launch of the improved EudraVigilance database system for collecting and monitoring suspected adverse reactions.

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 within the new regulations. The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionality for reporting and analyzing suspected adverse reactions.

The evolution of EudraVigilance (2001-2017)

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.

The benefits of the new EudraVigilance changes

The system's enhanced functionality for reporting and analyzing suspected adverse reactions is designed to better support the safety monitoring of medicinal products and allow a more efficient reporting process for stakeholders. More specifically, the EMA expects the new EudraVigilance database to bring the following benefits:

• Marketing authorization holders will no longer be required to submit Individual Case Safety Reports ("ICSRs") to individual national competent authorities. They will submit such reports directly to EudraVigilance, resulting in simplified reporting of ICSRs;
• The centralized nature of the EudraVigilance database will enable better detection of new or changing safety issues, allowing rapid action to protect public health;
• The broad access to reports of suspected adverse reactions by healthcare professionals and the general public via a public interface will increase transparency concerning suspected adverse reactions in the EEA;
• The enhanced database will result in increased system capacity and performance to support the large volumes of users and reports; and
• Since the EMA will make the reports of individual cases of suspected adverse reactions within the EEA available to the World Health Organization ("WHO") Uppsala Monitoring Centre directly from EudraVigilance, there will be a more efficient collaboration with the WHO.

To prepare for the system's official launch, users — including national authorities, marketing authorization holders, and clinical trial sponsors — must adapt their processes and local IT infrastructures to ensure they are compatible with the new system. The simplified electronic reporting of suspected adverse reactions related to medicines to EudraVigilance becomes mandatory on 22 November 2017. Therefore marketing authorization holders and competent authorities must be ready to start submitting all suspected adverse reactions into the new EudraVigilance system.

The EMA announced it intends to support national authorities, marketing authorization holders, and clinical trial sponsors in the EEA through targeted e-learning and face-to-face training, webinars, and information days. In addition, users are now able to test the new functions of the EudraVigilance system and the internationally agreed format for ICSRs in a test environment available since June 26, 2017.

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