WHO Issues New Procedure for Emergency Diagnostic Use

In the wake of declaring the coronavirus outbreak a global emergency, the World Health Organization (WHO) issued a new procedure for sponsors of medical products including diagnostic tests that wish to submit unapproved 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. In addition, the applicant must promise to finish developing the product and apply for WHO prequalification when and if the product is approved.