EudraVigilance: what’s changed?

Manufacturing Chemist
January 2018
Authors: David Balderson and Prashant Joshi, Sciformix Corporation

In May, 2017 the updates to the EudraVigilance system were approved for release and the changes went into effect on 22 November 2017, implemented by the European Medicines Agency (EMA).

The system is used to manage and analyze information on suspected adverse events to medicines that need to be reported in the European Union (EU). It is operated by the EMA on behalf of the EU medicines regulatory network. The system itself supports the safe and effective use of medicines by facilitating the electronic exchange of individual case safety reports between the EMA, national competent authorities, marketing authorization 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 authorized in the European Economic Area (EEA).

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