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SAHPRA Approves First WHO EUL Mpox Test Kit

SAHPRA, leveraging the WHO's Emergency Use Listing and Prequalification assessment through a "reliance process," has approved the first mpox in vitro diagnostic, a crucial step for global access to monkeypox testing.

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.

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NeoHealth® ID 38017 · updated 5/26/2025