WHO Publishes Submission Requirements for Emergency Use Listing of Bundibugyo Virus Diagnostic Tests (extranet.who.int)

• On 17 May 2026, WHO declared a PHEIC for Ebola disease caused by Bundibugyo virus in DRC and Uganda.
• WHO has now opened the EUL process for in vitro diagnostics detecting BDBV nucleic acid.
• Submission requirements include QMS documentation (ISO 13485 or equivalent), product dossier with analytical and clinical performance data.
• The EUL procedure aims to expedite availability of diagnostics for UN procurement agencies and member states.
• Manufacturers must submit in English with specific format and file naming conventions.

"The World Health Organization has released detailed instructions for manufacturers seeking Emergency Use Listing (EUL) of in vitro diagnostics detecting Bundibugyo virus (BDBV) nucleic acid. This follows the Director-General's declaration on 17 May 2026 of a Public Health Emergency of International Concern (PHEIC) for Ebola disease caused by BDBV in the Democratic Republic of the Congo and Uganda. The document outlines requirements for quality management systems, product dossier, analytical and clinical performance evidence, and post-market surveillance plans. It is intended to expedite availability of BDBV diagnostics during the PHEIC."