Emergency Use Listing : WHO
The World Health Organization (WHO) announced that it has listed the first mpox In Vitro Diagnostic (IVD) under its Emergency Use Listing (EUL) procedure.
- Emergency Use Listing procedure is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics.
- It aims 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.
- 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.
