The global pharmacovigilance specialist will help drive one of Africa’s most comprehensive medicines safety initiatives.
Qinecsa, the global pharmacovigilance specialist, has been selected as technology partner for AfriVigilance, the African Medicines Agency’s (AMA) new continent-wide medicines safety surveillance platform, with implementation already underway.
Described by AMA as the first system of its kind to connect medicines safety data across the entire product lifecycle – from clinical trials through to real-world use – AfriVigilance will strengthen the way that safety information is captured, shared and analyzed across Africa, supporting faster regulatory action and better patient outcomes.
Under AMA’s leadership and governance, Qinecsa will drive the platform’s consulting and technical delivery, providing its HaloPV case management and QVW signal detection and management technologies, underpinned by secure, Africa-based cloud hosting. The implementation builds on Qinecsa’s long-standing work supporting the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). As a technical partner to AMA, MHRA recommended Qinecsa’s technology for the project. The new platform will also draw on proven MHRA best-practice configurations to help accelerate delivery while supporting ongoing technical collaboration.
The project marks the next phase in Africa’s drive to strengthen medicines safety. Years of collaboration through the African Union’s Smart Safety Surveillance (AU-3S) program have demonstrated the value of shared safety reporting and cross-country collaboration. With the African Medicines Agency now established, AfriVigilance will turn that groundwork into a permanent, Africa-led capability.
The goal is to strengthen regulatory collaboration among African National Regulatory Authorities (NRAs), generate richer safety evidence for African populations, and improve patient safety across the continent. Development of the AfriVigilance platform was enabled through catalytic funding from the Gates Foundation, building on years of collaboration to strengthen medicines safety systems across Africa.
Dr Delese Mimi Darko, Director General of the African Medicines Agency, believes the new platform will play a vital role as Africa expands local manufacturing of medicines and vaccines. She said:
“As Africa expands local manufacturing of medical products, we must be equally rigorous about how we monitor their safety. AfriVigilance gives our National Regulatory Authorities and member states a continental system built on African data, for African populations, and this partnership with Qinecsa and our technical partners puts that ambition on a delivery footing.”
Commenting on the importance of the project and Qinecsa’s role in it, CEO Adam Sherlock said the collaboration reflects everything the company has been working towards: “Projects like this are built on trust. We’re incredibly proud that the African Medicines Agency in collaboration with African NRAs and working alongside the MHRA, has entrusted Qinecsa with such an important role. This is exactly why we exist: to combine deep pharmacovigilance expertise with innovation to solve complex safety challenges that make a real difference to patients. Helping to build a medicines safety capability at continental scale is an exciting opportunity, and one we’re immensely proud to be part of.”
The partners have already begun implementing AfriVigilance, laying the foundation for a stronger, more connected approach to medicines safety across Africa.
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About AfriVigilance
AfriVigilance is the African Medicines Agency’s (AMA) new continent-wide medicines, vaccines and medical devices safety surveillance platform. Building on the African Union’s Smart Safety Surveillance (AU-3S) program, it is designed to strengthen regulatory collaboration, connect safety data across the product lifecycle, and support more timely, evidence-based public health decisions across Africa. Visit https://au-ama.africa/about-overview/
About Qinecsa
Qinecsa is a global pharmacovigilance specialist with more than 20 years’ experience supporting pharma, biotech, and public health organisations. The company combines scientific expertise with a flexible, technology-powered platform to solve complex safety challenges, reduce fragmentation, and help teams work with greater clarity and accountability.
Focused solely on drug safety, Qinecsa provides independent services and advanced PV solutions trusted by leading life sciences organisations and health authorities worldwide. More at www.qinecsa.com