EMA publishes six-year review of EU pharmacovigilance

The European Medicines Agency (EMA) has published a paper reviewing EU pharmacovigilance arrangements implemented since legislative changes introduced in 2012.

The review showed 26,000 adverse events were recorded via the pharmacovigilance systems of manufacturers and national competent authorities, with 453 escalated to the EMA’s Pharmacovigilance Risk Assessment Committee. The majority of recommendations arising from these involved changes to product information to aid safer use.

The article is available here.

Another publication from the EMA, co-authored by EMA Director Guido Rasi and PRAC Chair Sabine Straus, looks at how pharmacovigilance is likely to change over the next decade. The article discusses the impact of technology, smarter use of data, and more proactive engagement to ensure pharmacovigilance advice is optimally adopted.

The article is available here.

The EMA press release summing-up the work on pharmacovigilance is available here.

Tagged with

Published 1. December 2019 in News, News EU