The South African Health Products Regulatory Authority (SAHPRA) notes with concern the statement made on Cape Talk Radio that the regulatory authority has issued the first commercial licences for the growing and manufacturing of cannabis. The mandate of the regulatory authority is to issue licences...
The South African Health Products Regulatory Authority (SAHPRA) has learned about the safety concerns regarding the presence of a nitrosamine impurity called NDMA in ranitidine-containing medicines. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the results of...
SAHPRA is pleased to announce the appointment of a new Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, who will commence with this role in January 2020. Dr Semete-Makokotlela holds a Ph.D. in Biochemistry (North-West University) and an MSc in Management Finance and Investment from Wits Business...
Mr Khamusi Mutoti, Biological Medicine Manager at SAHPRA, was elected the Chairperson of the African Blood Regulator’s Forum (ABRF) during the African Medicines Regulation Conference (AMRC) held at Elephant Hill Hotel, Victoria Falls, Zimbabwe on 2 – 4 October 2019. Mr Mutoti who is also an...
The South African Health Products Regulatory Authority (SAHPRA) is updating certain active pharmaceutical ingredient (API) names used in South Africa to bring them into line with international nomenclature. Further name changes are also taking place – to improve consistency within South African approved terminology 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...
The Medicines Control Council (MCC) of South Africa wishes to alert healthcare professionals that the use of oral cough and cold medicines containing certain ingredients is now contraindicated in children under the age of two years. This decision is in line with international recommendations regarding the...
The Medicines Control Council wishes to inform prescribers of increased risks of cerebrovascular adverse events (including strokes and transient ischaemic attacks) and mortality associated with the use of atypical antipsychotics in elderly patients with dementia. The atypical antipsychotics to which this medicine safety alert refers...
The Medicines Control Council (MCC) wishes to alert healthcare professionals and consumers to the risk of adverse events associated with the prolonged or repeated use of gamma benzene hexachloride (lindane)-containing shampoos (Gambex® and Quellada® Shampoos). After a review of the risk-benefit profile of these products, the...
The Medicines Control Centre (MCC) wishes to draw the attention of all health care professionals to the correct route of administration of Rotarix Vaccine. Rotarix Vaccine is indicated for the prevention of gastroenteritis caused by Rotavirus, G1 and non- G1 serotypes (such as G2, G3, G4...
