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SAHPRA fast-tracks M-pox test approval under African medicines harmonisation process

# The South African Health Products Regulatory Authority has approved the Cobas MPXV test for M-pox after a fast nine-day review using the African medicines regulatory harmonisation process. The approval, which also relied on the World Health Organisation emergency use listing, expands South Africa’s diagnostic capacity for early detection, timely treatment, and prevent the virus from spreading. SAHPRA spokesperson Yuven Gounden says the process marks a milestone in regional and continental regulatory harmonisation for medical devices.