16 Mar SAHPRA and the Pfizer/Biontech Comirnaty Vaccine
16 March 2021 SAHPRA has approved the Section 21 application for the Pfizer/Biontech Comirnaty Vaccine. Download PDF ...
Author: Ntokozo Msiza
12 Mar SAHPRA and the CoronaVac Vaccine
12 March 2021 SAHPRA received documentation for the Coronavac vaccine developed by Sinovac on 10 March 2021 SAHPRA will now commence with evaluating the data in assessing the efficacy of the vaccine. Download PDF ...
24 Feb Update: SAHPRA and the SputnikV Vaccine
24 February 2021 SAHPRA has received documentation for the SputnikV vaccine developed by the Gamaleya Institute in Russia on 24 February 2021. SAHPRA will now commence with evaluating the data provided for safety, quality and efficacy of the vaccine. Download PDF ...
18 Feb SAHPRA and Rollout to President and Deputy President
18 February 2021 SAHPRA has approved the protocol amendment of the J&J implementation study targeted at Health Care Workers (HCW) for the inclusion of the President and the Deputy President. Whilst they are not classified as HCW, this initiative would assist greatly in encouraging vaccine uptake...
03 Feb SAHPRA clarifies its stance on Ivermectin
03 February 2021 There is an erroneous notion that SAHPRA “buckled under pressure” as a consequence of the court action brought by, amongst others the Afriforum regarding access to Ivermectin. SAHPRA wishes to state unequivocally that this is NOT the case. The court deliberations of 2 February...
28 Jan Update on the use of ivermectin in the prevention or treatment of COVID-19
28 January 2021 The second wave of the COVID-19 epidemic in South Africa has put enormous pressure on all aspects of South Africa’s health system and on its communities. SAHPRA appreciates the frustration and pain experienced by healthcare practitioners, patients and families given the limited availability...
27 Jan SAHPRA AUTHORISES COVISHIELD – AN ADENOVIRUS-VECTORED VACCINE FOR THE PREVENTION OF COVID-19
27 January 2021 In an effort to enable and support the country’s response in fighting the COVID-19 pandemic, SAHPRA has on 22 January 2021 granted a Section 21 authorisation to the Department of Health for COVISHIELD (a covid-19 vaccine manufactured by Serum Institute of India) for...
06 Jan SAHPRA OTC ONLINE DIRECTORY
06 January 2021 SAHPRA is pleased to announce the commencement of the build of an online directory for over the counter (OTC) SAHPRA approved medicines. This will include all Schedule 0, 1 and 2 registered OTC medicines. A launch date of May 2021 is anticipated. The domain...
22 Dec Extension of Post Importation Testing Exemptions
22 December 2020 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 30 April 2021 without further need of an application thereof. The initial approval date was extended to...
19 Dec Frequently Asked Questions: New Variant of SARS-CoV-2 in South Africa
19 December 2020 Health Minister Dr Zweli Mkhize on Friday announced that a variant of the SARS-COV-2 Virus (COVID-19) – currently termed the ‘501.V2 Variant’ – has been identified by genomics scientists in South Africa. Download PDF ...