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...
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...
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...
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing the final pharmaceutical products for immediate and extended release dosage forms containing metformin hydrochloride as an active substance. This review was triggered because of the detection of an impurity,...
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all ranitidine-containing medicines with the following Active Pharmaceutical Ingredient; ranitidine. SAHPRA previously issued a media release regarding the recall and quarantine of ranitidine containing medicines (29 October 2019 and...
10 May 2019 SAHPRA is the South African Health Products Regulatory Authority. It is a Section 3A public entity that was formed by the South African government to oversee the regulation of health products which includes medicines, medical devices, in-vitro diagnostic tests and devices, radiation emitting...
