How WHO's Global Surveillance and Monitoring System works
The Global Surveillance and Monitoring System is WHO's channel for national regulators to report substandard and falsified medical products. WHO checks reports, links incidents across countries and issues Medical Product Alerts in the most serious cases.
- WHO launched the Global Surveillance and Monitoring System for substandard and falsified medical products in July 2013.1,2
- Trained focal points in national medicine regulatory authorities submit reports to WHO through an electronic rapid alert form and, since 2016, a secure web portal.1
- WHO says reports are uploaded to a secure WHO database and compared against all reports. For reports indicating adverse reactions WHO contacts the sender within 24 hours, otherwise it responds within 72 hours.1
- WHO may provide technical assistance, from access to a specialist laboratory to on the ground help investigating the root cause, and may issue a public medical product alert where there is a significant threat to public health.1,2
- Before issuing an alert WHO considers criteria such as whether the report has been validated, whether there is a significant public health threat and whether the risk extends beyond the first country.3
- WHO says 10% of substandard and falsified products reported to the system are associated with a toxic reaction, while 90% do not cause a toxic reaction but fail to treat the intended condition.4
Sources
- World Health Organization, WHO Global Surveillance and Monitoring System (2026)
- World Health Organization, Substandard and falsified medical products: WHO activities (9 December 2019)
- World Health Organization, Medical product alerts: background (2026)
- World Health Organization, Post market surveillance of substandard and falsified medical products (2026)