SIGNAL

SIGNAL is a newsletter about potential medicines safety issues, known as signals, derived from individual case safety reports in VigiBase.

Communicating signals

UMC communicates signals of suspected medicines safety problems to national pharmacovigilance centres through SIGNAL, and subsequently to the wider world via WHO Pharmaceuticals Newsletter. Signals are based on information derived from individual case safety reports in VigiBase

Is it a signal?

UMC performs periodic screenings of VigiBase to identify previously unknown or incompletely documented ADRs. Pharmacovigilance experts at UMC and experienced scientists and clinicians from the UMC Signal Review Panel, assess the clinical evidence and decide whether or not it is strong enough to represent a signal. Read more about UMC's signal detection here

From signal to action

Signals communicated in SIGNAL represent suspected causes of harm, with varying levels of likelihood; they usually need further evaluation or action. Signals are primarily intended to alert and inform national regulatory authorities which are responsible for deciding if further action is required. Such action may include communicating the information to health professionals and the responsible market authorisation holders; changing the information for patients; providing a public alert or warning; or in the most serious situations, withdrawing a drug from the market.

The distribution of SIGNAL is restricted to national centres and regulatory authorities in countries that are members of the WHO Programme for International Drug Monitoring. Individual signals are sent to the appropriate pharmaceutical company when they can be identified as uniquely responsible for the drug concerned. Since 2012, UMC signals have been subsequently published in WHO Pharmaceuticals Newsletter, publicly available online.

Last modified on: September 28, 2018
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