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...
01 July 2021 The South African Health Products Regulatory Authority (SAHPRA) has reduced the time taken to register COVID-19 vaccines to less than three months where the required standard of data is available, while continuing to adhere to strict guidelines to ensure the safety of South...
25 June 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...
23 June 2021 SAHPRA has received documentation for the Sinopharm vaccine developed by the China National Pharmaceutical Group in China. SAHPRA will now commence with evaluating the data in assessing the efficacy of the vaccine. Download PDF ...
21 June 2021 The South African Health Products Regulatory Authority (SAHPRA) is an independent health products regulatory authority, governed by national legislation, whose mandate is to ensure the safety, quality and efficacy of health products available in South Africa. These essential requirements have been similarly applied...
13 June 2021 SAHPRA registered the Covid-19 Vaccine Janssen on 31 March 2021, with conditions. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965. The Covid-19 Vaccine Janssen is an adenovirus type 26 vectored vaccine indicated for...
7 June 2021 SAHPRA registered the Covid-19 Vaccine Janssen on 31 March 2021, with conditions. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965. The Covid-19 Vaccine Janssen is an adenovirus type 26 vectored vaccine indicated for...
22 April 2021 SAHPRA is pleased to announce the launch of the Med Safety App. The Med Safety App is a mobile application (App) that is designed to simplify and promote the reporting of suspected adverse drug reactions (ADRs), including adverse events following immunisation (AEFIs) by...
21 April 2021 SAHPRA refutes claims made by the President of the Black Farmers Association of South Africa (BFASA) that SAHPRA has an inclination towards White bias. SAHPRA treats All applicants equally and with respect and does not practise any prejudice in its dealings with all stakeholders,...
17 April 2021 SAHPRA has engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica. The focus of the engagement was on the safety data reported from the Sisonke study, following administration of the COVID-19 vaccine Janssen, as well as the adverse events reported...
