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EU’s Pharmacovigilance System: A ‘New Era Of Safety & Transparency’

There Have Been 450 Safety Recommendations in Six Years

Executive Summary

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.

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