27 Aug SAHPRA Approves Mpox Test Using African Medicines Regulatory Harmonisation (AMRH) Continental EUL Procedure
Pretoria, 27 August 2025 –The South African Health Products Regulatory Authority (SAHPRA) has approved a molecular test kit for Mpox , Cobas MPXV, for use on the Cobas 6800/8800 Systems, within nine working days through a collaborative and harmonised review process under the African Medicines Regulatory Harmonisation (AMRH). Rapid and accurate testing is essential for early detection and to enable timely treatment, and effective containment of the virus.
SAHPRA’s Medical Device Unit, utilising both the World Health Organization (WHO) Emergency Use Listing (EUL) report and the African Medicines Regulatory Harmonisation (AMRH) Continental EUL Procedure, has successfully leveraged reliance mechanisms to facilitate the review and approval of Mpox diagnostic tools. This approach has proven instrumental in accelerating access to critical health technologies, particularly in public health emergencies.
The emergency use approval of the Cobas MPXV for use on the Cobas 6800/8800 Systems, developed by Roche Molecular Systems, Inc. and licensed to Roche Diagnostics South Africa (Pty) Ltd, represents a critical advancement in expanding diagnostic capacity amid Mpox outbreaks. Rapid and accurate testing is essential for early detection, timely treatment, and effective containment of the virus.
“As part of our efforts to promote regulatory efficiency and responsiveness, SAHPRA has successfully leveraged reliance mechanisms to facilitate the review and approval of Mpox diagnostic tools. This marks a significant milestone in supporting regional and continental harmonisation of the regulatory processes for medical devices, including In-Vitro Diagnostics (IVDs),” says Dr Boitumelo Semete-Makokotlela, SAHPRA’s Chief Executive Officer.
For more information on the AMRH continental EUL listing publication, see here: https://www.nepad.org/news/public-notice-amrh-steering-committee-approves-emergency-use-listing-of-two-mpox
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