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What is a Signal ?

Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.

A signal often relates to all medicinal products containing the same active substance, including combination products. Certain signals may only be relevant for a particular medicinal product or in a specific indication, strength, pharmaceutical form or route of administration whereas some signals may apply to a whole class of medicinal products

Signal management process:

A set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking. The EU signal management process includes the following activities: signal detection, signal validation, signal confirmation, signal analysis and prioritization, signal assessment, and recommendation for action