VigiBase® is a unique repository of international drug safety data. The data is available in a wide range of services, from advanced statistical analysis to basic case report retrieval
Since 1978 the Uppsala Monitoring Centre (the UMC) has been the focal point of independent global pharmacovigilance. The VigiBase data resource is the largest and most comprehensive in the world, and it is developed and maintained by the UMC on behalf of the World Health Organization (WHO). In VigiBase you find useful information about the safety profile of medicinal products. The services described are used by pharmaceutical companies, academia and national regulatory authorities to obtain safety data with global coverage. VigiBase data is collected from the over 110 countries participating in the WHO Programme for International Drug Monitoring. VigiBase comprises over 10 million Individual Case Safety Reports, ICSRs, and the current growth rate is about 1 million ICSRs each year. ICSRs in VigiBase are primarily spontaneous reports, meaning that they are not generated in controlled clinical trials, but in post-marketing settings, i.e. it is 'real world' data.
Some uses for VigiBase data:
- Statistical signal detection
- Updating PSURs (Periodic Safety Update Reports)
- Comparison with ICSRs in company databases
- Comparing domestic and international reporting patterns
Access the data in different ways
VigiBase data is primarily accessible to all National Pharmacovigilance Centres of the WHO Programme member countries through a tailor-made search and analysis tool, VigiLyze™, only available to staff at National Pharmacovigilance Centres. More information on VigiLyze may be found here.
Data is also made available through vendors providing signal detection solutions. The dataset provided to the vendors is complete in number of ICSRs, but limited in case level information, to allow for statistical disproportionality analysis without compromising patient privacy. A current list of vendors including VigiBase data in their products is found here.
It is also possible to request data directly from the UMC by specifying search parameters and desired output format in discussion with a specialist professional – UMC provides these tailor-made search services to academia, pharmaceutical companies, national centres and regulatory authorities. Instructions on how to order are found here.
Data access policy (currently under revision): Access to ICSR data.pdf
VigiBase® facts and background: Read more about VigiBase®
Marketing material: VigiBase® tri-fold brochure.pdf