28 Jan Reprocessing of Single Use Medical Devices_Communication to Stakeholders_Nov2019
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Reprocessing of Single Use Medical Devices_Communication to Stakeholders_Nov2019
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04 Apr SAHPRA joins the Medical Device Single Audit Programme
Pretoria, 04 April 2025 –The South African Health Products Regulatory Authority (SAHPRA) has joined the Medical Device Single Audit Programme (MDSAP), an international audit programme of medicines and medical device regulators aimed at improving efficiencies in the regulation of medical device manufacturers by engaging in work...
29 Apr Guidance on the use of the Janssen Ad26.COV2.S (COVID-19) vaccine in pregnant and lactating women
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...
08 Nov SAHPRA’s position on GLP1 and GIP-GLP1 products that are compounded, substandard and falsified
Pretoria, 08 November 2024 –The South African Health Products Regulatory Authority (SAHPRA) is concerned about the proliferation of falsified, compounded and substandard Glucagon-like Peptide (GLP-1)-containing products being made available to the public via websites, social media platforms and other informal channels. These pose a health...
06 Apr SAHPRA withdraws pholcodine-containing medicines from SA market
Pretoria, 06 April 2023 – The South African Health Products Regulatory Authority (SAHPRA) has made the decision to withdraw pholcodine-containing medicines from the South African (SA) market due to the increased risk of sudden, severe, and life-threatening allergic reactions occurring during surgery. There is a...
04 Aug Update on COVID-19 Vaccine Janssen – Guillain-Barré syndrome
04 August 2022 On 31 March 2021, SAHPRA approved the use of the COVID-19 Vaccine Janssen for individuals 18 years of age and older as a single primary vaccination dose. COVID-19 Vaccine Janssen was later approved as a single booster dose given at least two...
24 Jun SAHPRA registers the COVID-19 vaccine, Coronavac
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...12 May Safety of the COVID-19 Vaccine Janssen – response to restrictions imposed in the United States
12 May 2022 Embargo: Immediate release In both the United States and South Africa, the COVID-19 Vaccine Janssen has been approved as a single primary vaccination dose, a single booster dose at least two months after the primary vaccination dose, and as a heterologous booster...
21 Apr SAHPRA Refutes Claims Made by the Black Farmers Association of South Africa (BFASA)
21 April 2021 SAHPRA refutes claims made by the President of the Black Farmers Association of South Africa (BFASA) that SAHPRA has an inclination towards White bias. SAHPRA treats All applicants equally and with respect and does not practise any prejudice in its dealings with...- 1
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