28 January 2021 The second wave of the COVID-19 epidemic in South Africa has put enormous pressure on all aspects of South Africa’s health system and on its communities. SAHPRA appreciates the frustration and pain experienced by healthcare practitioners, patients and families given the limited availability...
27 January 2021 In an effort to enable and support the country’s response in fighting the COVID-19 pandemic, SAHPRA has on 22 January 2021 granted a Section 21 authorisation to the Department of Health for COVISHIELD (a covid-19 vaccine manufactured by Serum Institute of India) for...
22 December 2020 Post Importation Testing Exemptions (PITE) granted due to COVID-19 pandemic Post importation testing exemption approvals granted since March 2020 due to the Covid-19 pandemic, are extended to 30 April 2021 without further need of an application thereof. The initial approval date was extended to...
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 ...
15 December 2020 With the advent of COVID-19, vaccine development is a critical area of need. SAHPRA has been proactive and is prepared for the vaccine registration process. The readiness programme includes the establishment of a specialised working group, the COVID-19 Vaccine Registration Working Group (CVr...
10 December 2020 What is a Covid-19 Vaccine? A COVID‑19 vaccine is any of several different vaccine technologies intended to provide immunity against coronavirus disease 2019 (COVID‑19).1 In general, vaccines contain weakened or inactive parts of a particular organism (antigen) that triggers an immune response within the...
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...
SAHPRA and B4SA under the Pharmaceutical and Vaccines working stream are collaborating on providing industry with regulatory guidance to ensuring essential Covid-19 related medicines supply in both the public and private sector are well managed in a clear and transparent manner. To this end, the regulatory...
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...
