Communicating signals
Uppsala Monitoring Centre communicates signals of suspected medicines safety problems to national pharmacovigilance centres and subsequently to the wider world via the WHO Pharmaceuticals Newsletter or in scientific journals.
Signals communicated by UMC 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 withdrawing a drug from the market.
Signals are distributed from UMC via VigiLyze (UMC’s signal detection and management system) to national centres and regulatory authorities in countries that are members of the WHO PIDM. Individual signals are sent to the appropriate pharmaceutical company when they can be identified as uniquely responsible for the drug concerned.