Signal analysis and prioritisation by the PRAC

For the signal management process in the EU, the process by which the Pharmacovigilance Risk Assessment Committee (PRAC) determines whether a confirmed signal requires further assessment, and if required, to what timeframe and in which procedural framework, based on an initial analysis of the potential impact of the signal on patients’ or public health and the risk-benefit balance of the concerned medicinal product(s).

See also Signal management process