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Communication Regarding the Development of a Policy Relating to the Issuing of Licences in Terms of Section 22c(1)(B) of the Medicines and Related Substances Act, 101 of 1965, in Accordance With Broad-based Black Economic Empowerment Principles

Home >  Communication Regarding the Development of a Policy Relating to the Issuing of Licences in Terms of Section 22c(1)(B) of the Medicines and Related Substances Act, 101 of 1965, in Accordance With Broad-based Black Economic Empowerment Principles

10 Apr

Posted at 15:39h in

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,...

09 Apr

Posted at 14:43h in

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...

09 Apr

Posted at 14:41h in

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...

09 Apr

Posted at 14:39h in

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...

09 Apr

Posted at 14:29h in

Reckitt Benckiser Pharmaceuticals (Pty) Ltd in collaboration with the South African Health Products Regulatory Authority (SAHPRA), wish to draw your attention to the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome associated with the use of pseudoephedrine-containing medicines....

09 Apr

Posted at 09:03h in

In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Johnson and Johnson (Pty) Ltd would like to inform you about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines....

04 Apr

Posted at 17:27h in

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....

03 Apr

Posted at 14:41h in

The South African Health Products Regulatory Authority (SAHPRA) Engagement Portal launched on 01 April 2025. We thank applicants for embracing the new system, quickly adapting to it, and promptly bringing to our attention any challenges encountered. This communication seeks to resolve a frequently encountered challenge...