WHO Emergency Use Listing Procedure Revision (August 2022) (extranet.who.int)

• Replaces the previous EUAL mechanism with the updated EUL procedure.
• Applies to unlicensed vaccines, therapeutics, and IVDs during PHEICs or other designated emergencies.
• Establishes a pre-emergency phase to enable rapid listing once an emergency is declared.
• Incorporates lessons from the 2014-2016 Ebola and Zika outbreaks.
• Clarifies roles of NRAs and reliance on their assessments.

"The World Health Organization published an updated Emergency Use Listing (EUL) procedure in August 2022, replacing the former Emergency Use Assessment and Listing (EUAL) mechanism. The EUL is a risk-based procedure for assessing unlicensed vaccines, therapeutics, and in vitro diagnostics during public health emergencies, primarily Public Health Emergencies of International Concern (PHEIC). It outlines pre-emergency and emergency phases, eligibility criteria, and assessment pathways. The revision aims to clarify procedural aspects, improve regulatory preparedness, and facilitate rapid listing decisions. The document draws on lessons from the 2014-2016 Ebola outbreak and subsequent Zika response."