A Description of Signals During the First 18 Months of the EMA Pharmacovigilance Risk Assessment Committee

Conclusions The importance of spontaneous reporting in signal detection and monitoring of safety issues throughout the entire life cycle of a medicinal product is confirmed in this study. The amount of time a drug has been on the market is correlated with the number of signals detected. The PRAC decision-making process seems efficient particularly with respect to serious concerns; its role in improving signal prioritization and real-time signal management will be further clarified in its subsequent years of operation.
Source: Drug Safety - Category: Drugs & Pharmacology Source Type: research