How will the Updated EudraVigilance System Impact Pharma Companies and the Industry?

PharmacoVigilance Review
February 2018
Author: Prashant Joshi, Sciformix Corporation

The EudraVigilance system is used to manage and analyse information on suspected adverse reactions to medicines that need to be reported in the European Union. It is operated by the European Medicines Agency (EMA) on behalf of the European Union medicines regulatory network, and the EMA have recently given the green light to an updated EudraVigilance system to improve the existing database. Effective from 22 November 2017 this will be implemented by the EMA.

The update has been much anticipated in the industry, following the planned independent audit of the system completed earlier in 2017. The revisions are in line with the recommendations provided by the Pharmacovigilance Risk Assessment Committee (PRAC) and will ensure the database achieves full functionality and the
system meets the operational specifications endorsed by PRAC1.

The system itself supports the safe and effective use of medicines by facilitating the electronic exchange of individual case safety reports (ICSRs) between the EMA, national competent authorities, marketing authorisation holders (MAHs) and the World Health Organization (WHO). It also facilitates the early detection and evaluation of possible safety signals and enables better product information for medicines authorised in the European Economic Area (EEA).

Read the full article.