AU-3S Expands Drug Safety Surveillance across Africa with Continental Database

Addis Ababa, May 5, 2025 (ENA) -- The African Union’s Smart Safety Surveillance (AU-3S) program, spearheaded by African Union Development Agency (AUDA-NEPAD), is advancing drug safety in Africa through innovation and regional collaboration. 

Now in its second phase, AU-3S is supporting 12 African countries in building a continental database to track the safety of essential medicines and vaccines.

This data-driven network enables health authorities to report, analyze, and respond to adverse drug events in real time—strengthening regulatory systems and enhancing public health outcomes.

Speaking to ENA, AU-3S Coordinator Ken Onu explained, “We provide an end-to-end solution, from event reporting to signal management and ensure that no one is left behind.”

He emphasized AU-3S’s collaboration with regional economic communities to promote regulatory harmonization and improve access to safe and effective medical products.

Prof. Mojisola Christianah Adeyeye, Director General of NAFDAC Nigeria, noted that before AU-3S, Nigeria’s pharmacovigilance system was underdeveloped.

“Joining the AU-3S platform helped us tremendously, especially in reaching WHO maturity level three. The digital tools and safety app significantly boosted the quality and volume of reports while harmonizing standards,” she said.

David Nahamya, Secretary of Uganda’s National Drug Authority on his part stressed the importance of regional cooperation.

“With 1.4 billion people, African countries must work together to regulate medicines and promote local production. Currently, 75% of our medicines are imported. We need to reduce this reliance and manufacture within the continent,” Nahamya stated.

He called for leveraging Africa’s common market to scale pharmaceutical manufacturing, investing in scientific validation of indigenous medicine, and improving data sharing to strengthen drug safety oversight.

“Medicines are one of the most expensive parts of healthcare,” he said, adding that “Access to safe, affordable medicines requires coordinated action and long-term investment in stronger health systems.”

AU-3S now covers seven additional products in five major disease areas, including malaria, tuberculosis, HIV/AIDS, polio, and COVID-19.

The program promotes safer and more accessible medical products while strengthening health system resilience across the continent.

Launched in 2020, the program is funded by the Bill and Melinda Gates Foundation, with the UK’s MHRA as a technical partner.