Essential medicines and health products

WHO Emergency use assessment and listing procedures for medical products during public health emergencies

There are no proven preventive or therapeutic products for Ebola virus disease (EVD). When WHO and international partners began to fast-track R&D for potential Ebola diagnostics, treatments and vaccines, there was no guidance available on how to test any candidate products in an emergency situation, or how to regulate them. To address this, WHO has designed a set of procedures to evaluate the three product categories for acceptable performance, quality and safety, to accelerate use of these tools during the epidemic. The creation of Emergency Use Assessment and Listing procedures (EUALs) has resulted from this work. EUALs are already being used for Ebola diagnostics. The EUALs have gone through extensive consultation with international partners, the affected countries and stringent regulatory authorities, and are the first such procedures of a global nature. The EUALs developed for the Ebola emergency will be extended to all public health emergencies of international concern in the future.