In 2020, as the world dealt with the COVID-19 pandemic, Africa faced an unprecedented challenge: ensuring medical product safety amidst the fast rollout of new vaccinations and treatments. The urgency of the situation necessitated a coordinated, data-driven strategy to pharmacovigilance-one that could cross borders and foster long-term resilience.
This is where the African Union Smart Safety Surveillance (AU-3S) Programme originated. AU-3S, led by AUDA-NEPAD, aims to strengthen regulatory procedures, improve safety surveillance, and assist national authorities in monitoring medical products. What began as a response to a global catastrophe has since become a pillar of Africa’s health security.
Over the last five years, AU-3S has connected national regulatory authorities (NRAs) from various AU Member States. It improved digital safety surveillance with platforms such as AfriVigilance Lite. It also developed partnerships and cooperation to help strengthen the vigilance system. It improved signal management and data-driven decision-making, resulting in safer healthcare.
This year’s 6th AU-3S (African Union Smart Safety Surveillance) Steering Committee conference was held in Addis Ababa, Ethiopia, with a focus on enhancing safety surveillance systems and creating capacity for priority medical items to simplify cross-country signal handling in Africa. Key conversations were held to expand country participation, advance data integration, and promote the African Medicines Agency’s (AMA) operationalization.
The route to a strong, self-sustaining pharmacovigilance system in Africa is well begun. AU-3S remains a light of progress in guaranteeing safe and effective medical products for all Africans, because to its strong leadership, innovative alliances, and constant devotion.
Despite AU-3S’s progress and performance over the last five rounds, it is necessary to ask how Ethiopia has worked to attain the AU-3S objective. How has the AU-3S been performing? What challenges have you faced?
Ethiopian Minister of Health Dr. Mekdes Daba recalled that “how the COVID-19 pandemic tested the very foundations of African health systems. The swift rollout of novel vaccines, limited safety data within African populations, and emergency use authorizations highlighted a glaring need: a strong, coordinated, and proactive pharmacovigilance system tailored to our realities.”
In response, the AU-3S Programme emerged not only as a timely solution but also as a flagship initiative of AUDA-NEPAD—positioning Africa to take charge of its own medical safety landscape.
Since its inception in 2020, AU-3S has made significant strides that include pilot implementation in five key member states (including Ethiopia) that cover 30% of Africa’s population, the establishment of the African Union Pharmacovigilance Risk Assessment Committee (AU-PRAC) to lead joint signal management activities, extensive capacity building and training, empowering our national regulatory authorities, the creation of the Vigilance Hub, a digital platform revolutionizing real-time safety data sharing across borders, and most importantly, expanding reach, ensuring broader participation, inclusivity, and stronger representation across regions and languages.
She stated that these achievements are not just milestones; they are building blocks of a safer, more resilient healthcare future for our continent. Ethiopia is proud to have been one of the two entry points for the COVAX facility into Africa. This strategic position, coupled with our AU-3S participation, has enabled us to harness digital innovation in pharmacovigilance, enhancing our ability to report, respond to, and prevent adverse events in real time.
As the AU-3S Programme continues to grow, expanding to include more countries, more products, and more disease areas; it must remain anchored in collaboration, scientific rigor, and a unified vision for patient safety.
She also urged them, “Let us be guided by a shared vision: A continent where safe, quality-assured medical products are the norm, not the exception; where regulatory systems are empowered; and where every public health decision is backed by reliable safety data.”
AUDA-NEPAD Director Kenneth Onu told The Ethiopian Herald that Ethiopia has been trying to strengthen Smart, Safety, and Surveillance programs, which are critical to achieving Pan-Africanism in the health sector.
Ethiopia’s efforts in drug control and monitoring serve as an example for the African Union’s health sector. The country’s engagement in the sector also significantly helps the continent’s efforts to meet the health goals outlined in Agenda 2063, according to AUDA-NEPAD.
He added “Ethiopia, along with Ghana, Kenya, Nigeria, and South Africa, was Africa’s top priority for medical products. The country also submitted the most adverse event reports for the COVID-19 vaccine, which was the primary product of interest when it was piloted. Additionally, it was one of the entries for the COVAX vaccine into Africa. So we’ve come a long way in Ethiopia.”
“Ethiopia has provided us with significant assistance in moving on with our program’s long-term goals, and we are currently in the expansion phase to include more countries from five geographical regions and eight regional economic communities in Africa. So we are extremely optimistic that Ethiopia will continue its support in the future,” he stated.
“Agenda 2063 is our baby.” We are driving Agenda 2063’s implementation. We are currently in the second ten-year implementation phase, known as the decade of acceleration. As a result, Ethiopia is doing its part in the health sector to see a healthy, prosperous Africa, with safe, effective, and high-quality medical items in its healthcare delivery systems,” he stated.
Ethiopian Food and Drug Authority (EFDA) Director General Heran Gerba said, “Ethiopia in general, and the EFDA in particular, are fully committed to the long-term goals of the AU-3S initiative, which include increasing AU Member States’ safety surveillance.”
She added, “As one of the Wave (1) pilot countries, we have benefited immensely from the various solutions deployed by the AU-3S program which includes access to sub-delegation support, opportunities to participation in joint capacity strengthen initiatives, participation in the activities of the joint Signal Management group and contribution of adverse events safety platform to combined cross-country platform.
“As the program expands to cover additional member states in Africa and also in the scope of priority medical products, EFDA will continue to participate and also support other new countries deploying the principle of the 3S strategy- reliance, data, and work sharing and prioritization”, she explained.
As the story of AU-3S shows, Africa does indeed have a promising future in creating a safer healthcare system. If all of the AU’s member nations begin cooperating and uniting, this can be strengthened. Because Ethiopia’s or AU-3S’s efforts alone won’t be sufficient to guarantee secure continuity in the absence of cooperation.
BY EPHREM ANDARAGCHEW
THE ETHIOPIAN HERALD TUESDAY 1 APRIL 2025
