The Global Pharmacovigilance Framework · Section 2.3
~5 min read · The Drug Safety Coach — Global PV Career Course
Key points
Full text
The WHO Programme for International Drug Monitoring was established in 1968 as the first global infrastructure for sharing drug safety data across national boundaries. It operates today through the Uppsala Monitoring Centre in Sweden, the WHO Collaborating Centre for International Drug Monitoring.
VigiBase is the most comprehensive global repository of spontaneous safety reports — covering products in markets that regional databases like EudraVigilance or FAERS may not individually represent. VigiLyze provides the analytical layer: disproportionality analysis, time-trend analysis, subgroup exploration, available to registered users from national authorities, academic institutions, and qualifying researchers.
VigiFlow is the web-based ICSR management system that countries without their own national safety database use to collect, process, and transmit reports into VigiBase — India’s PvPI reports, for example, are transmitted to VigiBase through VigiFlow.
The distinction between VigiBase, VigiLyze, and VigiFlow trips people up in interviews because the names sound interchangeable — but they sit at three different layers of the same system: VigiFlow is how a country without its own infrastructure gets data in, VigiBase is where that data lives once aggregated globally, and VigiLyze is the tool analysts actually use to query and analyse it. A country can use VigiFlow without ever touching VigiLyze; a researcher can use VigiLyze without knowing which countries used VigiFlow versus their own national systems to contribute their reports.
2026 Update
In 2025, the WHO-UMC launched its AI Hub — a global collaboration platform for developing, validating, and sharing trustworthy AI tools for pharmacovigilance, including federated signal detection algorithms that can run across national databases without sharing raw data. This is a direct operational output of the CIOMS WG XIV recommendations.
Quick check
Test yourself before moving on — no pressure, just click an answer.
1. What year was the WHO Programme for International Drug Monitoring established, and what prompted it?
2. A country with no national PV database of its own wants to contribute reports to VigiBase. Which tool do they use?