Emergency use listing procedure

The World Health Organization (WHO) developed the Emergency Use Assessment and Listing  (EUAL) mechanism in response to the 2014 – 2016 Ebola Virus Disease (EVD) outbreak. The EUAL is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics (IVDs) for use primarily during public health emergencies of international concern (PHEIC) but also in other public health emergencies if appropriate.

Two submissions for Ebola vaccines were received but none was listed. No therapeutic products that were in development were submitted during the 2014-2016 Ebola outbreak. Twenty- five applications for IVDs were received for Ebola assays of which seven were listed. Also, three out of thirty- three applications received for Zika assays were listed.

Based on the above experience, vaccine developers and national regulators identified the need to revise and simplify the procedure, in order to improve clarity on procedural aspects, and to avoid overlap or gaps in their respective functions.