31 March 2022 SAHPRA has assigned a non-compliant rating to the Emergent BioSolutions COVID-19 facility based on new data received. This was following a collaborative inspection which was conducted both onsite and via remote inspection. This means that SAHPRA will not accept any drug products or...
As part of its ongoing response to COVID-19 communications and following a series of successful public events, the South African Health Products Regulatory Authority (SAHPRA) will be hosting a Webinar on “Vaccine Safety and Adverse Events”. The propose of the Webinar is to provide a...
11 March 2022 Embargo: Immediate release The South Africa Health Products Regulatory Authority (SAHPRA) has noted that a safety report in relation to the COVID-19 Pfizer Comirnaty vaccine directed to the United States Food and Drug Administration (FDA) has been distributed on various communication platforms in South...
SAHPRA was joined by experts to discuss the latest updates on Covid-19 therapies. Date: Monday, 21 February 2022 Time: 11h30 - 12h30 Speakers 1. Dr. Boitumelo Semete-Makokotlela, SAHPRA CEO 2. Prof. Hannelie Meyer, NISEC committee chairperson 3. Prof Andy Parish, HOD of Internal Medicine (Walter Sisulu University) 4. Dr Jeremy Nel, Infectious Diseases...
17 February 2022 Embargo: Immediate release Until recently, the treatment options for patients with mild-to-moderate COVID-19 have been limited. New oral antiviral medicines are becoming available for the treatment of confirmed COVID-19 in adults who do not require supplemental oxygen and who are at risk of...
adria Crehuet Cano via Unsplash...
23 December 2021 Embargo: Immediate release The South African Health Products Regulatory Authority (SAHPRA) initially registered the COVID-19 Vaccine Janssen, with conditions on 30 March 2021, in terms of section 15 of the Medicines and Related Substance Act (Act 101 of 1965). On 10 December 2021, SAHPRA received...
8 December 2021 Embargo: Immediate release The South African Health Products Authority (SAHPRA) initially approved the use of Pfizer’s Comirnaty® COVID-19 vaccine on 16 March 2021, in terms of section 21 of the Medicines and Related Substance Act (Act 101 of 1965). On 17 November 2021, SAHPRA received...
26 November 2021 Embargo: Immediate release SAHPRA has received an application for the Pfizer Comirnaty Booster/3rddose vaccine on 17 November 2021. This is for the homologous booster regimen, not a mix-and-match approach. SAHPRA will now commence with the assessment of data for the safety and efficacy of the third...
Enhancing the public trust in COVID-19 vaccination: Progress and challenges in the regulation, administration and rollout of vaccines in South Africa. The race for countries to reach herd immunity continues globally. The prolonged Covid-19 pandemic has adversely affected the social and economic standing of many nations...
