AU-3S Steering Group Meeting

SAHPRA hosts 3rd AU-3S Steering Group Meeting, new member countries welcomed

Pretoria, 14 September 2023 –The South African Health Products Regulatory Authority (SAHPRA) was the host country for a robust and engaging African Union Smart Safety Surveillance (AU3S) in-person Steering Group Meeting held on 11 – 12 September 2023 in Cape Town.  AU-3S is a flagship programme of the African Union Development Agency (AUDA-NEPAD).

The meeting welcomed four new countries as members of the Steering Group, namely, the Egyptian Drug Authority, the Congolese Pharmaceutical Regulatory Authority (ACOREP), Senegal’s Pharmaceutical Regulatory Agency (ARP), and the Rwanda Food and Drug Authority.  The current Steering Group of national regulators authorities (NRAs) are SAHPRA, Ghana Food and Drug Authority (Ghana FDA), Ethiopian Food and Drug Authority (EFDA), Kenya’s Pharmacy and Poisons Board, and Nigeria’s National Agency for Food and Drug Administration (NAFDAC).

Key deliberations

There were key deliberations on the draft roadmap and recommendations from the AU-3S ad hoc Continental Safety Monitoring Platform Working Group (CWG) on seven focus areas for the ongoing programme expansion – continental (geographical and language) coverage, product scope, signal management, technology optimisation and AfriVigilance, pre-licensure safety data, stakeholder engagement and sustainability and finance. Revision of the terms of reference regarding the expansion of the steering group (SG), and implementation of the programme since the last SG meeting were also discussed.

“This in-person engagement has allowed us, as member countries of NRAs, to make key decisions to expedite the AU-3S initiatives regarding pharmacovigilance and related systems to continue on the path to protect patients across the continent through our safety surveillance programmes,” explains Dr Boitumelo Semete-Makokotlela, SAHPRA CEO.

“This third meeting of the Steering Group has provided clear directions as to how the AU-3S programme should be scaled up so that it continues to serve the continent in ensuring the safety of patients in Africa. It is a great opportunity that African countries are now able to make decisions on safety of vaccines and other therapies based on African data”, recounts Aggrey Ambali, Senior Advisor, AUDA-NEPAD.

“This meeting has set a clear direction on the further expansion of the AU-3S programme”, says Mick Foy, Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA) UK, adding that the “MHRA have facilitated capacity strengthening and the collection and safety analysis of safety data and are committed to continuing supporting the AU-3S programme for the benefit of patient safety”.

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