The EU’s pharmacovigilance system appears to have performed well since it was strengthened in 2012, with 26,000 potential signals assessed and more than 450 safety recommendations issued. However, there is still room for improvement, and it would be useful to compare the system with that of other regulators, say the authors of a study on the first six years of the EMA’s pharmacovigilance committee.
EMA officials say the EU drug safety signal system is performing well • Source: Shutterstock
In the six years following its creation in 2012, the European Medicines Agency’s pharmacovigilance committee (PRAC) issued 453 recommendations, just over half of which were for drug labeling changes.
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