Ethiopia's Robust Regulatory Framework Vital Cornerstone for Africa’s Health Sovereignty: AMA

Addis Ababa, February 21, 2026 (ENA) –Ethiopia’s robust regulatory framework positions the nation as a vital cornerstone for Africa’s transformative regional health sovereignty, African Medicines Agency (AMA) Director-General Dr. Delese Mimi Darko said.

In an exclusive interview with the Ethiopian News Agency (ENA), the Director-General applauded the Ethiopian Food and Drug Authority for achieving WHO Maturity Level 3, a prestigious designation that marks the agency as a stable, well-functioning, and internationally recognized body.

 Ethiopia is on a good ground because you have a good regulatory agency, she said, adding that

once your regulator is strong, the regulator will ensure that you have good practice.

 According to Dr. Darko, Ethiopia is very lucky to have a drug authority that is WHO Maturity Level 3.

 The drug authority can support the industry to ensure they manufacture in accordance with good manufacturing practices and that good quality products come out, she stated.

 The Director-General emphasized that such domestic strength is decisive for reversing Africa’s heavy dependance on foreign imports, noting that the continent currently imports over 70 percent of its medical products and manufactures a mere 1-2 percent of its vaccines.

 Dr. Darko framed this change as a matter of "health sovereignty," ensuring that in times of pandemic or emergency, Africa is no longer at the compassion of global supply chains.

 "Africa wants to get to the point where it manufactures its own medical products for its continent," the Director-General said, adding that the African Medicines Agency will make sure that we put the right system so that nobody says that Africa manufactured a product that is not good.

 To realize this, the agency is championing a one-harmonized system designed to eradicate the bureaucratic hurdles of navigating 55 different member states, she revealed. 

 Dr. Darko said that the agency's primary mission is to streamline the pathway for investors by centralizing approval and authorization processes.

"We want to make it painless for investment. If we have that one harmonized pathway, then investors are more likely to want to invest in Africa."

By enhancing the capabilities of the continent's 9 established regulatory agencies, the AMA intends to establish a cohesive, top-tier environment in which safe and high-quality medical products become the standard in Africa.

 The African Medicines Agency (AMA) is a specialized agency of the African Union (AU) established to harmonize medical product regulation across the continent, ensuring access to safe, effective, and high-quality medicines.

 Headquartered in Kigali, Rwanda, it aims to reduce regulatory fragmentation, fight counterfeit products, and streamline clinical trials.