Ethiopia Reinforces Its Role in Africa’s Health Sovereignty
Addis Ababa, February 21, 2026 – Ethiopia is emerging as a pivotal player in Africa’s health sovereignty, bolstered by a robust regulatory framework, according to Dr. Delese Mimi Darko, Director-General of the African Medicines Agency (AMA).
Ethiopia’s Regulatory Achievements
In a recent interview with the Ethiopian News Agency (ENA), Dr. Darko praised the Ethiopian Food and Drug Authority for attaining the WHO Maturity Level 3 status. This designation signifies that the agency is a stable, well-functioning entity recognized internationally, laying the foundation for strong healthcare practices.
“Ethiopia is on solid ground because you have a competent regulatory agency,” Dr. Darko emphasized, underlining the importance of strong governance in ensuring best practices in drug regulation.
Strengthening Local Manufacturing
Dr. Darko highlighted the necessity of having a competent drug authority to foster compliance with good manufacturing practices, ensuring that quality medical products are developed domestically. This local strength is crucial for reducing Africa’s heavy reliance on imports, as the continent currently imports over 70% of its medical products and produces merely 1-2% of its vaccines.
“Achieving health sovereignty means that Africa will not be at the mercy of global supply chains during crises,” Dr. Darko added.
A Vision for Self-Sufficiency
Dr. Darko articulated the AMA’s vision for Africa to become self-sufficient in medical product manufacturing. She stated, “Africa wants to reach a point where it manufactures its own medical products for its continent,” emphasizing the need for high-quality standards in production to counter any external skepticism.
To facilitate this ambition, the AMA is advocating for a harmonized regulatory system that addresses the bureaucratic challenges posed by navigating the diverse regulatory landscapes of 55 member states.
Improving Investment Conditions
Dr. Darko also discussed the agency’s mission to streamline approval processes for investors, stating, “We aim to create a painless investment environment. A unified regulatory pathway will encourage more investors to engage in Africa’s healthcare sector.”
By enhancing the capabilities of the continent’s established regulatory agencies, the AMA plans to cultivate an environment where safe and high-quality medical products are ubiquitous.
Understanding the African Medicines Agency
The African Medicines Agency is a specialized agency of the African Union (AU), dedicated to harmonizing medical product regulations across the continent. With a focus on ensuring the availability of safe, effective, and high-quality medicines, the agency is headquartered in Kigali, Rwanda.
Its objectives include reducing regulatory fragmentation, combating counterfeit products, and streamlining clinical trials, ultimately ensuring that African populations have better access to essential medicines.
For further insights into the role of the AMA in fostering health sovereignty, visit African Medicines Agency and explore their strategic vision.
Conclusion
Ethiopia’s advancements in regulatory frameworks and its commitment to improving local manufacturing capabilities signal a transformative shift for Africa’s healthcare landscape. With continued support and investment in regulatory systems, the continent can aspire to true health sovereignty, paving the way for a more resilient and self-sufficient future in medical product manufacturing.
