OR WAIT 15 SECS
August 11, 2016
On August 8, 2016, the European Commission (EC) announced the publication of a
that highlights the collaboration between the European Medicines Agency (EMA), the EC, and European Union Member States in the implementation of pharmacovigilance legislation. The report emphasizes that the collaboration has “enhanced the monitoring of the safety of human medicines throughout their lifecycle, for the benefit of patients.”
The report describes the activities of the EU system for monitoring drug safety from July 2012, when new pharmacovigilance legislation came into effect, until July 2015. According to EMA, the report shows that the new system has been successful at quickly detecting safety issues and is effectively engaging patients and healthcare professionals. EMA stated in a press release that the Pharmacovigilance Risk Assessment Committee (PRAC), a committee dedicated to drug safety, and “the regulatory tools made available under the revised legislation, allow for a more proactive approach to ensuring medicine safety.”
Highlights from the report include:
can be viewed on the EC’s website.