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.
This document provides an overview of desired skillsets for persons required by SAHPRA who will be considered to serve in the African Traditional Medicines Working Group to support SAHPRA in considering and developing the regulatory approach for ATMs and make recommendations to the SAHPRA Chief Executive Officer (CEO).
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
In the interest of public health, SAHPRA has launched the COVI-Vig reporting system for vigilance and monitoring of health products being used for prevention or treatment of COVID-19 outside of a clinical trial and outside of the MEURI framework.
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.