Pretoria, 30 January 2023 – The South African Health Products Regulatory Authority (SAHPRA) has registered Paxlovid, an anti-viral medicine manufactured by Pfizer, to treat COVID-19. Paxlovid, which contains Nirmatrelvir (150mg) and Ritonavir (100mg), is a medicine that is used for the treatment of mild to moderate...
Pretoria, 24 November 2022 – In the past year, the South African Health Products Regulatory Authority (SAHPRA) approved the antigen test kits for use by healthcare professionals. SAHPRA has now approved seven (7) COVID-19 antigen self-test kits that can be used as self-test/ at home tests...
22 November 2022 Embargo: Immediate release Pretoria, 22 November 2022 - The South African Health Products Regulatory Authority (SAHPRA) has registered Pfizer’s COMIRNATY Ready To Use (RTU) ADULT VACCINE and Dilute To Use (DTU) PAEDIATRIC VACCINE on 15 November 2022. The RTU vaccine, as the name...
Embargo: Immediate release Pretoria, 24 June 2022 – The South African Health Products and Regulatory Authority (SAHPRA) registered the COVID-19 vaccine, Coronavac, on 14 June 2022, with conditions. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of...
17 June 2022 CEO Perspectives and Horizons as Covid-19 takes a grip The SAHPRA CEO, Dr Boitumelo Semete-Makokotlela shares her journey since she assumed the position of CEO. She unpacks how she had to face a “sink or swim” situation as the COVID-19 pandemic gripped South Africa...
07 June 2022 Embargo: Immediate release1. The COVID-19 vaccine LHC has been registered with conditions on 24 May 2022.The registration of the COVID-19 vaccine LHC was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965. This COVID-19 vaccine (Sinopharm...
03 May 2022 Embargo: Immediate release Pretoria, 3 May 2022 - In October 2021, the African Christian Democratic Party (ACDP); Free the Children -Save the Nation NPC, Caring Healthcare Workers Coalition NPC, and the COVID Care Alliance NPC initiated court action against the Minister of Health and...
31 March 2022 SAHPRA has assigned a non-compliant rating to the Emergent BioSolutions COVID-19 facility based on new data received. This was following a collaborative inspection which was conducted both onsite and via remote inspection. This means that SAHPRA will not accept any drug products or...
As part of its ongoing response to COVID-19 communications and following a series of successful public events, the South African Health Products Regulatory Authority (SAHPRA) will be hosting a Webinar on “Vaccine Safety and Adverse Events”. The propose of the Webinar is to provide a...
11 March 2022 Embargo: Immediate release The South Africa Health Products Regulatory Authority (SAHPRA) has noted that a safety report in relation to the COVID-19 Pfizer Comirnaty vaccine directed to the United States Food and Drug Administration (FDA) has been distributed on various communication platforms in South...
