30 September 2021 Attention all stakeholders 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 March 2022 without further need of an application thereof. Post-Importation Testing Exemptions (PITE) expiring prior to...
10 September 2021 The South African Health Products Authority (SAHPRA) has approved the use of the Pfizer COMIRNATY Vaccine in terms of Section 21 of the Medicines and Related Substance Act 101 of 1965 (The Medicines Act) to include individuals twelve years (12) years and older....
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...
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...
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...
