Under the leadership of AUDA-NEPAD, the African Union’s Smart Safety Surveillance (AU-3S) programme was launched in early 2020, with the long-term goal of strengthening the safety surveillance of priority medical products across the African continent. The programme is being funded by The Bill and Melinda Gates Foundation (BMGF) with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a technical partner.

 The programme aims to address limited health system and safety surveillance[1] capacity across Africa through efficiencies like technological innovation, pooling of resources and work sharing. With COVID-19 further reinforcing the need for strong African PV systems, AU-3S is currently piloting its approach on the safety surveillance of COVID-19 vaccines in four countries. These countries are Ethiopia, Ghana, Nigeria, and South Africa – altogether comprising ~30% of Africa’s population. The AU-3S team works closely with the medical products[2] Regulatory Authorities and Expanded Programmes on Immunisation (EPIs) from these countries.

The AU-3S programme is governed by a steering group which is comprised of the medical products Regulatory Authority CEOs from the 4 pilot countries, the UK MHRA and U.S. Food and Drug Administration (FDA) as technical partners, and AUDA-NEPAD as the grantee and BMGF as the funders.  The WHO is represented on the steering group by both AFRO and EMRO regional offices.  Furthermore, AU-3S is taking part in continental initiatives to ensure a collaborative and coordinated response to the COVID-19 pandemic, including the WHO-AFRO led African COVID-19 Vaccine Deployment Readiness and Execution Taskforce (ACREDT) and the Africa CDC led African Vaccine Delivery Alliance (AVDA).

In the longer term, the programme will expand its scope to include additional countries and cover other novel/innovative products for the AU priority diseases areas: HIV, TB, Malaria and other emergency products.

For more information about the AU-3S programme, download the latest AU-3S information pack, click here.

[1] Also known as pharmacovigilance (PV)

[2] Includes medicines, vaccines, and medical devices