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...
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 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...
15 December 2020 With the advent of COVID-19, vaccine development is a critical area of need. SAHPRA has been proactive and is prepared for the vaccine registration process. The readiness programme includes the establishment of a specialised working group, the COVID-19 Vaccine Registration Working Group (CVr...
10 December 2020 What is a Covid-19 Vaccine? A COVID‑19 vaccine is any of several different vaccine technologies intended to provide immunity against coronavirus disease 2019 (COVID‑19).1 In general, vaccines contain weakened or inactive parts of a particular organism (antigen) that triggers an immune response within the...
04 December 2020 Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, SARS- CoV-2. The rapid spread of this virus has resulted in the COVID-19 pandemic that has led to a dramatic loss of human life worldwide and presents an unprecedented challenge...
12 November 2020 SAHPRA wishes to correct the inaccuracies in the Medical Brief article titled “High Court rules that SAHPRA not to regulate alternative medicines” published on 4 November 2020. On 01 October 2020, the Pretoria High Court delivered its judgment in the matter between the...
In collaboration with the South African Health Products Regulatory Authority (SAHPRA), Roche Products (Pty) Ltd would like to inform you of the risk of drug-induced liver injury (DILI) associ- ated with use of Esbriet® (pirfenidone): The Professional Information (PI) and Patient Information Leaflet (PIL) will be updated...
SAHPRA alerts all healthcare professionals about the risk of serious heart problems, seizures, coma and death associated with the use of high doses of diphenhydramine- containing medicines. The South African Health Products Regulatory Authority (SAHPRA) wishes to alert healthcare professionals about the risk of serious heart...
