13 April 2021 We have noted the decision taken by the Food and Drug Administration in the United States of America to advise the temporary suspension of the Johnson and Johnson vaccine rollout in the US. This has occurred to due reports of 6 females who developed...
9 April 2021 On 6 April 2021 the Pretoria High Court issued a court order pertaining to four cases that were brought against SAHPRA and the Minister of Health regarding access to Ivermectin for use in COVID-19. The court order was as a result of settlement...
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...
