On 31 December 2019, the World Health Organization (WHO) reported a cluster of pneumonia cases in Wuhan City, China. ‘Severe Acute Respiratory Syndrome Coronavirus 2’ (SARS-CoV-2) was confirmed as the causative agent of what we now know as ‘Coronavirus Disease 2019’ (COVID-19). Since then, the virus has spread to more than 100 countries, including South Africa.
A virtual meeting of 40 senior level participants from regional African agencies, African regulatory authorities, international regulatory authorities, the WHO, AUDA-NEPAD and academia from across Africa, Europe, the UK and the USA came together to discuss this topic.
Test kits are medical devices. Serological test kits (Rapid test kits), are finger-prick tests that do not need to be processed by the lab. The rapid test kits are able to detect if you have developed antibodies to COVID-19. Rapid test kits cannot be used for diagnosis.
Learn more about Rapid test kits
Pretoria, 20 October 2020 – SAHPRA refutes claims made by the Black Farmers Association of South Africa (BFASA) that SAHPRA is a corrupt entity with an inclination towards White bias, in the issuing of licenses, generally and particularly with respect to cannabis products.SAHPRA is subject to inter alia the Public Finance Management Act (“PFMA”), and therefore conducts itself with the utmost integrity and prides itself in the ethos of transparency.
The South African Health Products Regulatory Authority (SAHPRA) aims to clear its backlog within a period of two years. The backlog clearance programme went live on 1 August 2019.
The backlog clearance project will assume a three-pronged approach:
The South African Health Products Regulatory Authority (SAHPRA) is reviewing the scheduling status of codeine following the growing use of the non-medicinal use of codeine-containing medicines. Codeine is classified as an opioid. Opioids are narcotics with a known potential for dependence. Codeine is administered in liquid or solid form (tablet/capsule), either alone or in combination with other active pharmaceutical ingredients
Medicine safety alert: new restrictions on the use of gamma benzene hexachloride (lindane) – containing shampoos
The Medicines Control Council (MCC) alerts all health care professionals to the correct route of administration of Rotarix vaccine.
The Medicines Control Council (MCC) alerts all health care professionals to new prescribing information for promethazine.