Skip to main content

Mpox disease PHEIC - Emergency Use Listing Procedure (EUL) for IVDs

Mpox disease PHEIC - Emergency Use Listing Procedure (EUL) for IVDs

Mpox has been reported in the Democratic Republic of the Congo (DRC) for more than a decade, and the number of cases reported each year has increased steadily over that period. In July 2022, the multi[1]country outbreak of mpox was declared a Public Health Emergency of International Concern (PHEIC) as it spread rapidly via sexual contact across a range of countries where the virus had not been seen before. That PHEIC was declared over in May 2023 after there had been a sustained decline in global cases. However, last year, reported cases again increased significantly in DRC, and mpox continues to affect people around the world. The detection and rapid spread of a new clade (Clade Ib) of Monkeypox virus in eastern DRC, its detection in neighbouring countries that had not previously reported mpox, and the potential for further spread within Africa and beyond has prompted the renewal of its classification as a PHEIC as of 14 August 2024. 

On 28 August 2024 WHO published an invitation to manufacturers of Monkeypox virus IVDs:  

Please contact the In vitro diagnostics assessment team for further information at diagnostics@who.int

Information provided here consists of an overview of the evaluation progress of the active applications in the emergency use listing assessment of Monkeypox virus IVDs/ Nucleic Acid Tests. For each product the status for each stage of evaluation is given. 

The indication “R” means that information has been requested from the manufacturer and that the WHO is awaiting a reply and/or submission of additional documentation.

This list does not reflect a decision on EUL assessment and must not be used to inform procurement as it does not constitute an endorsement or WHO listing of the products. 

Status of ongoing applications: Monkeypox virus IVDs/ Nucleic Acid Tests

Click here to view the list of Mpox disease that have received WHO Emergency Use Listing for Monkeypox virus IVDs/Nucleic Acid Tests.