01 April 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...
29 March 2021 The SABC placed an erroneous report that “SAHPRA has agreed to allow the use of Ivermectin for the treatment of COVID-19”. This is grossly untrue, misleading to the public and irresponsible and could have dire consequences. The position of SAHPRA remains steadfast. Ivermectin may...
19 March 2021 SAHPRA has implemented a new and improved online submission portal for Section 21 applications (Category A Medicines). This has been in development over the past few months. The new submission portal will improve the communication timelines between SAHPRA and applicants. It also allows the...
19 March 2021 On 16 March 2021 SAHPRA registered Soolantra 10mg/g cream formulation, which contains ivermectin. The holder of the certificate of registration is Galderma South Africa. Soolantra Cream is indicated for the topical treatment of moderate to severe inflammatory lesions of papulopustular rosacea in adult...
16 March 2021 SAHPRA has approved the Section 21 application for the Pfizer/Biontech Comirnaty Vaccine. Download PDF ...
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 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 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 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 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...
