VigiBase, the WHO Global ICSR Database System: Basic facts

The main aim of the WHO International Drug Monitoring Programme, started in 1968, is to identify the earliest possible pharmacovigilance signals. The program now has more than 80 member countries from all parts of the world contributing individual case safety reports (ICSRs) to the WHO Global ICSR Database System, VigiBase. VigiBase is maintained and developed on behalf of WHO by the Uppsala Monitoring Centre (UMC), situated in Uppsala, Sweden. The database system includes the ICH E2B compatible ICSR database, the WHO Drug Dictionaries (WHO-DD and -DDE), and the medical terminologies WHO Adverse Reaction Terminology (WHO-ART), International Classification of Diseases (ICD), and the Medical Dictionary for Regulatory Activities (MedDRA). Apart from data management and quality assurance tools, the VigiBase system includes a web-based reporting tool, an automated signal detection process using advanced data mining, and search facilities, available to the member countries and, on request, to other stakeholders.