South Africa: SAHPRA Approves First Mpox Diagnostic Kit to Boost Access to Testing

South Africa: SAHPRA Approves First Mpox Diagnostic Kit to Boost Access to Testing

[SAnews.gov.za] The South African Health Products Regulatory Authority (SAHPRA) has announced the approval of the first WHO Emergency Use Listing (EUL) for a test kit for mpox.

SAHPRA Approves First WHO EUL Mpox Test Kit

Pretoria, 22 May 2025 –The South African Health Products Regulatory Authority (SAHPRA), having applied Reliance on the World Health Organization (WHO) PQ assessment under Emergency Use Listing, has listed the first mpox (monkeypox) in vitro diagnostic (IVD). This serves as an important step in improving global access to mpox testing by using a reliance process. The emergency use approval of the Alinity m... The post SAHPRA Approves First WHO EUL…