VigiBase
VigiBase: WHO’s global drug safety database
What is VigiBase?
- A global database of Individual Case Safety Reports (ICSRs) for medicines.
- The world’s largest drug safety data repository.
- Maintained for the World Health Organization by the Uppsala Monitoring Centre (UMC) in Sweden since 1978.
What is it used for?
- To learn about the safety profile of medicines.
- Used by pharmaceutical companies, researchers, and regulators to detect safety signals, update reports, compare with company data, and study how reports are made.
What data does it contain?
- ICSRs submitted by member states and other partners.
- As of 2014, it contained over 10 million ICSRs, with about 100,000 new reports each year (mostly after the drug is on the market).
Who contributes and how?
- Participating countries (125 member states and 28 associate members) submit ICSRs via their national centers.
- Reports usually come from drug manufacturers, healthcare professionals, or patients/consumers.
- Submissions are generally made in ICH E2B format and can be sent monthly or quarterly.
- For some countries, UMC provides VigiFlow, a web-based ICSR management system.
Who can access the data?
- Member states can access data through VigiSearch/VigiLyze or request data from UMC (narratives and lab data may be restricted for confidentiality).
- UMC staff have full access, including narratives and lab values.
- Paying customers (pharma companies or healthcare professionals) can request data for academic or public-interest use.
What does VigiBase include besides reports?
- It’s a relational database that uses SQL and supports various data tools.
- Includes automatic signal detection with VigiMine (a Bayesian data-mining method).
- Uses WHO Drug Dictionaries and standard vocabularies such as WHO-ART, ICD, and MedDRA.
What kinds of reports and medicines are included?
- Primarily post-marketing spontaneous safety reports (serious and non-serious).
- Some reports come from studies, clinical trials, or literature but may be flagged.
- Covers ordinary medicines, herbal/traditional remedies, biologics, vaccines, and medical devices.
- Also considers reports relating to medication errors, therapeutic failure, and counterfeit/substandard medicines.
Brief historical timeline
- 1957: Thalidomide tragedy highlights drug safety concerns.
- 1968: WHO pharmacovigilance program established.
- 1978: Operations moved to UMC (Sweden).
- 1991: Online database search becomes available.
- 1993: Documentation grading added to VigiBase.
- 1998: Automated signal detection using BCPNN method.
- 2001: Vigibase Online project begins (now VigiFlow).
- 2010: 100th country joins the program.
- 2014: Over 10 million ICSRs; more submissions from China begin.
This page was last edited on 1 February 2026, at 21:12 (CET).