11 June 2021 Background World Health Organization (WHO) estimates from 2017 indicates that 10.5% of medical products available in low- and middle-income countries (LMICs) are “substandard or falsified” (SF). Substandard health products are approved by the national regulators, but they do not comply with adequate standards due...
7 June 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...
07 June 2021 To whom it may concern We draw your attention to the provisions of Section 21 of the Medicine and Related Substances Act, 1965 (Act 101 of 1965), to authorise the sale of unregistered medicines or medical devices for certain purposes. The communication...
24 May 2021 Boitumelo Semete-Makokotlela’s children have nicknamed her “meeting”, because she spends so many evenings and weekends on virtual calls. A biochemist by training, she was appointed CEO of SA’s medicines regulator barely two months before the coronavirus crisis hit SA. Taking the helm at...
29 April 2021 Background Pregnant women are at higher risk of severe COVID-19 compared with women of childbearing age who are not pregnant, and COVID-19 has been associated with an increased risk of preterm birth. This document offers some preliminary recommendations on the use of the Janssen...
23 April 2021 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 September 2021 without further need of an application thereof. The initial approval date was extended to...
22 April 2021 SAHPRA is pleased to announce the launch of the Med Safety App. The Med Safety App is a mobile application (App) that is designed to simplify and promote the reporting of suspected adverse drug reactions (ADRs), including adverse events following immunisation (AEFIs) by...
17 April 2021 SAHPRA has engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica. The focus of the engagement was on the safety data reported from the Sisonke study, following administration of the COVID-19 vaccine Janssen, as well as the adverse events reported...
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...
