African Medicines Agency opens for full operations in Kigali as states align on quality and speed

Monday, 3rd November 2025.

by inAfrika Newsroom

African Medicines Agency has moved from treaties to daily work. Rwanda is hosting the headquarters, and Dr. Delese Mimi Darko is serving as inaugural Director-General after her June appointment. Moreover, African officials say the agency is now coordinating continental review and safety surveillance.

The mandate is clear. AMA aims to harmonise rules, accelerate approvals, and police falsified products. In addition, regulators plan joint assessments to reduce duplication that slows vaccine and drug access. Officials argue faster, trusted decisions will support local manufacturing and pooled procurement.

Kigali’s launch meetings focused on practical files. These include reliance pathways for priority products, inspection rosters for high-risk plants, and a shared database for adverse events. Consequently, national agencies can lean on AMA evaluations while keeping legal accountability at home.

Why it matters: African Medicines Agency can cut months from lifesaving decisions. During shocks — pandemics, cholera spikes, or supply crunches — continental coordination lowers prices and keeps quality high. Moreover, rapid action against substandard medicines directly protects households and public budgets.

For Africa, the signal is simple. Regulatory power is part of health sovereignty. Therefore, if AMA proves it can run consistent, science-based reviews, investors will back sterile plants, vaccine lines, and API facilities on the continent.

The risks are known. Funding must be predictable, and member states need to implement converged rules without political interference. In addition, data systems and inspector training must keep pace with new biologics and complex generics. If Kigali delivers on those basics, African Medicines Agency becomes a competitive asset, not just a new office