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...
20 August 2021 The South African Health Products Regulatory Authority (SAHPRA) has a mandate to oversee the safety, efficacy and quality of all medicines registered in South Africa, including vaccines. The National Department of Health (NDoH) Expanded Programme on Immunisation (EPI) is responsible for the COVID-19...
19 July 2021 As South Africa’s statutory health regulatory bodies, the South African Health Products Regulatory Authority (SAHPRA), Health Professions Council of South Africa (HPCSA), Office of Health Standards Compliance (OHSC), South African Nursing Council (SANC) and South African Pharmacy Council (SAPC) together with the National...
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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...
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...
11 June 2021 Background World Health Organization (WHO) estimates from 2017 indicates that 10.5% of medical products available in low- and middle-income countries (LMICs) are “substandard or falsified” (SF). Substandard health products are approved by the national regulators, but they do not comply with adequate standards due...
