Emergency Use Listing
07-10-2024
11:32 AM
1 min read
Overview:
The World Health Organization (WHO) announced that it has listed the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure.
About Emergency Use Listing:
- EUL Procedure is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics.
- Its aim is to expedite the availability of these products to people affected by a public health emergency.
- This will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data.
- Criteria for products listing under EUL
- The disease for which the product is intended is serious or immediately life threatening has the potential of causing an outbreak, epidemic or pandemic.
- Existing products have not been successful in eradicating the disease or preventing outbreaks.
- The product is manufactured in compliance with current Good Manufacturing Practices (GMP) in the case of medicines and vaccines and under a functional Quality Management System (QMS) in the case of IVDs.
Q1: What is Monkeypox?
It is a rare zoonotic viral disease caused by infection with the Mpox virus. The monkeypox virus belongs to the same family of viruses as the variola virus, the virus that causes smallpox.
Source: WHO approves first mpox diagnostic test for emergency use