WHO Posts New Procedure for Using Unapproved Drugs in Health Crises

In the wake of declaring the coronavirus a global emergency, the World Health Organization (WHO) has issued a new procedure for drugmakers that wish to submit unapproved drug products for public health crises.

The new Emergency Use Listing procedure assesses if unapproved vaccines, drugs and diagnostic tests could help mitigate public health emergencies, allowing them to skip parts of the regulatory approval process and reach patients more quickly.

Trials and tests needed to complete development must be underway at the time of submission, WHO said, and sponsors should not let the emergency use program interfere with ongoing trials.

The new strategy replaces the WHO procedure used during the 2014-2016 West African Ebola outbreak and comes as regulators and drugmakers around the world are pushing for medical countermeasures to the Wuhan coronavirus.