Signal assessment

The process of further evaluating a validated signal taking into account all available evidence, to determine whether there are new risks causally associated with the active substance or medicinal product or whether known risks have changed.

This process may include non-clinical and clinical data and should be as comprehensive as possible regarding the sources of information.

Within the signal management process in the EU, signal assessment by the Pharmacovigilance Risk Assessment Committee (PRAC), is, following PRAC’s initial signal analysis and prioritisation, the process of evaluating all available data relevant to a signal to determine the need for any regulatory action.

See also Validated signal, Signal management process, Signal analysis and prioritisation by the PRAC