Covid-19 Information and Communication

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.

There is a critical skills gap on the African continent in the regulatory sciences, and an acknowledged need to develop

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.

Rapid Test kits demystified

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

SAHPRA refutes claims by the Black Farmers Association

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.

Radio Interviews with the SAHPRA CEO on the BFSA claims

SAHPRA Backlog Clearance Programme Newsletter – Aug 2020

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:

• Reducing the number of applications that require evaluation
• Segment and prioritise remaining applications
• Design and implement new models for evaluation

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