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The South African Health Products Regulatory Authority (SAHPRA) is a statutory body established in terms of Section 2 of the Medicines and Related Substances Act, 101 of 1965, as amended. The objects of the Authority are to provide for the monitoring, evaluation, regulation, investigation, inspection,...

MPXV molecular test kit/s that have not been listed, registered or authorised for use in a jurisdiction recognised by the South African Health Products Regulatory Authority (SAHPRA) or that have not been pre-qualified by the World Health Organisation (WHO) will be screened against the minimal...

The first human case of Mpox was reported in the Democratic Republic of Congo; the outbreak has since spread to other countries, including South Africa. South Africa is currently experiencing an outbreak of Mpox clade II. Mpox (previously known as Monkeypox) is an infectious disease...

This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa. The regulatory requirements for Mpox diagnostics can be found in Communication to Industry: Issue No.: MD01-2024/25 v1...

The South African Health Products Regulatory Authority (SAHPRA) announces urgent webinars scheduled for Monday, 07 April 2025, Wednesday, 09 April 2025 and Friday, 11 April 2025 from 14:00-16:00....