The unique global resource at the heart of the drive for safer use of medicines

What is VigiBase?

VigiBase is UMC’s starting-point for the journey from data to wisdom about safer use of medicines and wise therapeutic decisions in clinical practice. It is the driving-force at the heart of the work of UMC and the WHO Programme. The purpose is to ensure that early signs of previously unknown medicines-related safety problems are identified as rapidly as possible.

VigiBase is the unique WHO global database of individual case safety reports (ICSRs). It is the largest database of its kind in the world, with over 25 million reports of suspected adverse effects of medicines, submitted, since 1968, by member countries of the WHO Programme for International Drug Monitoring. It is continuously updated with incoming reports.

About half of VigiBase data is from the USA, and about 20% from the EU, and many of these members have shared their data for up to 50 years. Asia is rapidly increasing its share, and the proportion of data from low- and middle-income countries increased over the past 5-10 years from under 5% to around 15%, making VigiBase a uniquely diverse and comprehensive data source.

Alongside its data management and quality assurance tools, the VigiBase system is linked to medical and drug classifications such as, MedDRA and WHODrug. These classifications enable structured data entry, retrieval and analysis at different levels of precision and aggregation, which are vital in order to enable effective and accurate analysis.

Covering around 99% of the world

UMC has developed and maintained VigiBase, the WHO global database of individual case safety reports (ICSRs), since 1978. Altogether, the WHO Programme members today represent close to 99% of the world’s population. Following the ten founder members of the late 60s, around 150 countries are now actively contributing data to VigiBase.

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