7 February 2022 SAHPRA registered the Comirnaty vaccine from Pfizer Laboratories Pty (Ltd) on 25 January 2022, with conditions. SAHPRA also SAHPRA registered the Covid-19 Vaccine MC Pharma on 31 January 2022, with conditions. SAHPRA is currently also evaluating a number of applications for emergency use (Section...
14 January 2022 Embargo: Immediate release Joint Media Statement The South African Health Products Regulatory Authority (SAHPRA) has signed a Memorandum of Understanding (MOU) with the U.S. Pharmacopeia (USP) to help expand the availability of health products, including medical devices, that are safe, efficacious, and of assured quality. SAHPRA,...
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...
7 December 2021 Please note that the SAHPRA office will be closed for the festive season from 12h00 on Friday the 24th of December 2021 and will re-open on Monday the 3rd of January 2022. In case of emergencies kindly contact the respective Senior Managers. Medical Devices and...
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...
22 November 2021 In June 2021, SAHPRA communicated that South Africa would not accept any product or ingredients made at the Emergent BioSolutions facility in Baltimore, Maryland until the Inspectorate conducted an onsite/remote inspection. This facility manufactures a drug substance used in some doses of the...
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...
18 October 2021 SAHPRA has been engaged in a rolling review of the data for the Sputnik V COVID-19 vaccine since the initial application was submitted on 23 February 2021. This vaccine was developed by the Gamaleya Research Institute of Epidemiology and Microbiology in the Russian...
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...
