Ebola IVD EUAL status after PHEIC termination

On 29 March 2016, WHO’s Director General announced that the Ebola situation in West Africa no longer constitutes a Public Health Emergency of International Concern, and that the temporary recommendations adopted in response should now be terminated. Consequently, WHO will no longer accept new applications of Ebola vaccines or in-vitro diagnostics (IVD) through the WHO Emergency Use Assessment and Listing (EUAL) mechanism. However, all IVD applications submitted prior to this announcement will continue to be assessed by WHO under the EUAL procedure. WHO encourages and welcomes manufacturers of IVD products already listed through the EUAL procedure, and/or new products, to apply for full prequalification.