Regulatory Systems Strengthening: Pharmacovigilance

Pharmacovigilance (PV), or monitoring the safety of pharmaceutical products after they are approved for sale, is a critical function of a national regulatory agency (NRA). By collating reports of patient adverse events from manufacturers, health workers, and patients, PV systems detect potential safety signals and help NRAs make evidence-based decisions regarding the on-going regulation of the product based on experience in larger, more representative populations than can be used in pre-marketing product testing. These decisions may include changes to public communications, prescribing guidelines, and marketing authorizations, including the need to do further testing, related to marketed pharmaceutical products.

When COVID-19 vaccines and therapeutics became available, African NRAs were confronted with a unique problem. Given the expedited approval process for those products, testing was relatively limited, with little information available about safety for African populations. African NRAs needed to quickly generate and analyze African data themselves, and the existing systems to do so were not adequately robust.

With Gates Foundation support, the African Union Development Agency set up the Smart Safety Surveillance Program (AU-3S) in 2020, which supported a pilot project of five African NRAs to collect and then pool their safety data and analyze it as a team.

The pilot countries were Ethiopia, Ghana, Kenya, Nigeria, and South Africa. Covering a population of over 450 million people, they worked together to enable new patient adverse event reporting pathways by rolling out the user-friendly Med Safety Application. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA), as a technical partner, supported countries to pool the cases in a new safety database (the Data Integration and Signal Detection, or DISD, system) and assisted with the creation of (and participated in) a Joint Signal Management Group to analyze the data. No new signals were identified, and the safety of the vaccines in African populations was confirmed to be like that in other populations.

Based on the success of the pilot project, AU-3S moved into a second phase in 2024, expanding to more countries, covering more products, and improving tools, technology, and governance.

Impact on the PV Ecosystem

Prior to AU-3S, pharmacovigilance systems in many African countries were underperforming. Fewer than 2% of patient adverse events reported globally originated from Africa, data systems were incomplete, fragmented, and largely paper-based, and trained staff were in short supply.

A key goal of AU-3S is helping countries progress through the WHO’s Global Benchmarking Tool (GBT) Vigilance Module (see the Maturity Level/GBT case study for more information). The ultimate objective of AU-3S is to help create an African-led, continent-wide framework for pharmacovigilance by helping countries and the new African Medicines Agency reach these vigilance standards.

Next Steps

The program continues to expand with 25 countries on track to participate by early 2026. Ongoing work includes the development of the continent-wide safety database (Afrivigilance), the implementation of the AU Pharmacovigilance Risk Assessment Committee (AU-PRAC), and the implementation of the Vigilance Technical Committee, all of which will support the African Medicines Agency in its pharmacovigilance remit. This work is critically important as more products are now being made available in Africa, especially through accelerated pathways. An end-to-end pharmacovigilance ecosystem for Africa will ensure that the continent is better prepared to tackle future health challenges, helping to safeguard millions of lives, and serving as a blueprint for LMICs worldwide.