A Thought Leadership Article by SAHPRA's CEO, Dr Boitumelo Semete-Makokotlela Introduction Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problems, which play a crucial role in ensuring public safety. The South African Health Products...
Pretoria, 11 March 2024 – On 05 January 2023, the COVID Care Alliance NPC and other applicants brought an urgent court application against the South African Health Products Regulatory Authority (SAHPRA), including the President of the Republic of South Africa and others to prevent people from...
Pretoria, 19 February 2024 – The Department of Health has noted a misleading voice-note making rounds on social media platforms claiming that people who vaccinated against COVID-19 are dying due to the vaccine. The voice-note promotes the use of an unregistered, over-the-counter product called “Nature`s Choice...
Pretoria, 26 October 2023 – The South African Health Products Regulatory Authority (SAHPRA) currently has four (4) COVID-19 vaccines which are under review, the COMIRNATY Bivalent paediatric and adult vaccines, mRNA (COMIRNATY Bivalent Infant DTU vaccine), and non-mRNA vaccine Coviccine. SAHPRA has so far registered three...
The South Africa Health Products Regulatory Authority (SAHPRA), in collaboration with Pharmacometrics Africa and tThe Department of Pharmacy and Pharmacology at the University of Witwatersrand, is pleased to announce the second cohort of graduates who successfully completed the short course for Clinical Assessors within African...
Pretoria, 15 May 2023 -The South Africa Health Products Regulatory Authority (SAHPRA) acknowledges and aligns itself to the statement issued by the World Health Organization (WHO) Director-General, declaring an end to the Public Health Emergency of International Concern (PHEIC) for the disease caused by the...
Pretoria, 30 January 2023 – The South African Health Products Regulatory Authority (SAHPRA) has registered Paxlovid, an anti-viral medicine manufactured by Pfizer, to treat COVID-19. Paxlovid, which contains Nirmatrelvir (150mg) and Ritonavir (100mg), is a medicine that is used for the treatment of mild to moderate...
Pretoria, 24 November 2022 – In the past year, the South African Health Products Regulatory Authority (SAHPRA) approved the antigen test kits for use by healthcare professionals. SAHPRA has now approved seven (7) COVID-19 antigen self-test kits that can be used as self-test/ at home tests...
22 November 2022 Embargo: Immediate release Pretoria, 22 November 2022 - The South African Health Products Regulatory Authority (SAHPRA) has registered Pfizer’s COMIRNATY Ready To Use (RTU) ADULT VACCINE and Dilute To Use (DTU) PAEDIATRIC VACCINE on 15 November 2022. The RTU vaccine, as the name...
Embargo: Immediate release Pretoria, 24 June 2022 – The South African Health Products and Regulatory Authority (SAHPRA) registered the COVID-19 vaccine, Coronavac, on 14 June 2022, with conditions. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of...
