Pretoria, 15 May 2023 -The South Africa Health Products Regulatory Authority (SAHPRA) acknowledges and aligns itself to the statement issued by the World Health Organization (WHO) Director-General, declaring an end to the Public Health Emergency of International Concern (PHEIC) for the disease caused by the...
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...
3 September 2021 The South African Health Products Regulatory Authority (SAHPRA) is aligned with the United States Food and Drug Administration (USFDA) call to not use Ivermectin for the treatment of COVID-19. This stance is reflected in the SAHPRA statement, dated 28 January 2021, outlining SAHPRA’s views on Ivermectin and the Controlled Compassionate Use Programme. SAHPRA...
30 July 2021 The South African Health Products Regulatory Authority (SAHPRA) is an independent, science-based entity that follows strict guidelines and processes when approving health products. SAHPRA concerns itself, like other regulators across the world, with safety, quality and efficacy of health products. These essential requirements...
26 July 2021 The South African Health Products Regulatory Authority (SAHPRA) would like to inform you of a signal of myocarditis/pericarditis associated with Pfizer-BioNTech’s Covid-19 vaccine, Comirnaty® (BNT162b2). The Pfizer/BioNTech Comirnaty® Vaccine was approved by SAHPRA in March 2021. The authorisation was done in terms of...
03 July 2021 The South African Health Products Regulatory Authority (SAHPRA) has authorised the CoronaVac COVID-19 vaccine, manufactured by Sinovac Life Sciences Co, and imported by Curanto Pharma (Pty) Ltd. The authorisation was done in terms of Section 21 of the Medicines and Related Substance Act...
19 December 2020 Health Minister Dr Zweli Mkhize on Friday announced that a variant of the SARS-COV-2 Virus (COVID-19) – currently termed the ‘501.V2 Variant’ – has been identified by genomics scientists in South Africa. Download PDF ...
04 December 2020 Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, SARS- CoV-2. The rapid spread of this virus has resulted in the COVID-19 pandemic that has led to a dramatic loss of human life worldwide and presents an unprecedented challenge...
30 March 2020 In line with the recommendation of the South African National Institute for Communicable Disease (NICD) and the recommendation of the World Health Organization (WHO), SAHPRA wishes to point out that the so-called Rapid test kits (serological test kits) that are being offered...
In line with the recommendation of the South African National Institute for Communicable Disease (NICD) and the recommendation of the World Health Organization (WHO), SAHPRA wishes to point out that the so-called Rapid test kits (serological test kits) that are being offered for the diagnosis...
