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Emergency Use Listing
Concept

Emergency Use Listing

WHO regulatory route allowing an unlicensed medical product to be used during a declared emergency.

Last refreshed: 14 July 2026 · Appears in 1 active topic

Key Question

How did WHO approve an Ebola test with no full licence in place?

Timeline for Emergency Use Listing

#92 Jul

Provided the regulatory route used to authorise the first BDBV diagnostic

Pandemics and Biosecurity: WHO lists first Bundibugyo Ebola test
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Common Questions
What is WHO's Emergency Use Listing?
Emergency Use Listing is WHO's regulatory route for allowing an unlicensed medical product to be used during a declared emergency once WHO has vetted its quality and performance.Source: Lowdown pandemics-and-biosecurity briefing
How does a product get an Emergency Use Listing?
A manufacturer submits quality, safety and performance data to WHO, which independently reviews it and can list the product for procurement without full national licensure.Source: Lowdown pandemics-and-biosecurity briefing
Has WHO used Emergency Use Listing before this Ebola outbreak?
Yes. EUL was the standard route for COVID-19 vaccines and rapid tests, and for mpox vaccines during the 2022-2023 emergency.Source: Lowdown pandemics-and-biosecurity briefing

Background

WHO added the first molecular diagnostic for Bundibugyo virus to its Emergency Use Listing on 2 July 2026, the first BDBV-specific test ever listed. Testing capacity across the affected DRC provinces has risen from roughly 200-400 tests a day at two facilities to more than 2,000 a day across ten laboratories.

EUL is WHO's regulatory route for using an unlicensed medical product during a declared public-health emergency, once WHO has independently vetted its quality, safety and performance. It does not replace national regulatory approval, but it lets WHO and partner agencies procure and deploy a product immediately, shrinking the gap between a laboratory breakthrough and a syringe or swab reaching a rural clinic. It was the standard vehicle for fast-tracking COVID-19 vaccines and rapid tests, and mpox vaccines during the 2022-2023 emergency. A listing lapses once WHO declares the emergency over, at which point continued sales require separate national licensure.

For Bundibugyo, a species with no approved vaccine or treatment, EUL is currently the only route by which any new diagnostic or therapeutic tool can reach patients this year. The mechanism's value is most visible in health systems that lack the capacity to run their own rapid national approval process, which is why it remains WHO's default lever whenever a laboratory breakthrough needs to reach an active outbreak fast.

More questions
Why did Bundibugyo Ebola not have a diagnostic test until July 2026?
No BDBV-specific molecular test had ever been listed before; WHO's R&D Blueprint had flagged the gap in March 2026, three months before this outbreak surfaced.Source: Lowdown pandemics-and-biosecurity briefing
What happens to an Emergency Use Listing once an outbreak ends?
The listing lapses once WHO declares the public-health emergency over. A manufacturer must then pursue separate national regulatory approval to keep selling the product.