Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use

During the 10 years of observation, 78 incidents were reviewed by the Incident Review Network and addressed through routine measures. Their number has varied throughout the years with a significant decrease after 2012. Incidents mainly covered safety (56%) and quality (34%).

Source:

Pharmacoepidemiology and Drug Safety