SOUTH AFRICA – The Cabinet of South Africa has approved the signing of the African Union (AU) treaty establishing the African Medicines Agency (AMA) and submitted it to Parliament for ratification.
According to the governing body, the regulatory approval will give effect to the treaty that was adopted by the African Union Assembly in 2019 and the treaty formally establishes the AMA for the continent.
“Even so, ratification of the AMA treaty by the South African parliament remains a critical step before the deal is sealed. Following that, the treaty ratification then needs to be formally deposited with the African Union,” the body highlighted.
The Cabinet announced in an official statement that the agency will regulate medical products and improve the safety and efficacy of the medical products for the continent.
“In the context of the framework, the AMA will contribute to strengthening laboratories for drug quality control and promote the education of pharmacists in identifying sub-standard or falsified drugs, using innovative tests to measure drug quality,” the advisory body said.
The Cabinet further said that the treaty, once ratified by fifteen member States of the African Union, will encourage policies that promote the availability of genuine, safe and effective products at competitive prices.
“The Framework also promotes collaboration with governmental and non-governmental partners to increase awareness amongst not only clinicians and pharmacists but also veterinarians and animal and crop producers about substandard and falsified antimicrobials,” the Cabinet noted.
As a key regional manufacturing centre for vaccines and the site of the World Health Organization’s (WHO) mRNA vaccine hub, it is vital for South Africa to be involved in AMA as Africa builds its vaccine manufacturing capabilities.
“If the South African Parliament ratifies the treaty, South Africa will be the 34th country to swing behind the AMA since the treaty took force in November 2021 with the ratification of the first 15 African countries to get behind the initiative,” the statement said.
The advisory body further pointed out that the signing and ratifying of this treaty will advance South Africa’s global and continental commitment toward strengthening the continental regulatory system on its health products.
The country also has a vibrant patient and civil society community that will enrich the continent-wide discussions on how to involve the public and patients in a more meaningful way in health products regulations as the AMA takes shape.
“South Africa’s move holds special relevance since its national regulatory agency is one of the few in Africa that has achieved the milestone of being designated as “maturity level 3” (ML3) by WHO,” the statement added.
The nascent AMA will also promote a common scheme for prohibiting the sale of non-standard antimicrobials, whose use can foster drug resistance, backed by post-marketing surveillance.
At the same time, AU Special Envoy to the AMA, Michel Sidibé, and the AMA Treaty Alliance (AMATA) are also engaging patient groups, industry, academia and civil society to support the AMA treaty and its operationalization.
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