EFDA Attains WHO Maturity Level 3 in Medicine Regulation
For Immediate release
Ethiopia has reached Maturity Level 3 (ML3) in the World Health Organization’s global classification of national regulatory authorities. This makes it the ninth country in Africa to reach this important milestone. It shows Ethiopia’s strong commitment to providing safe, effective, and high-quality medical products for its people.
Addis Ababa, Ethiopia – September 29, 2025 – The Ethiopian Food and Drug Authority (EFDA) proudly announces its attainment of Maturity Level 3 (ML3) for medicine regulation, a prestigious designation given by the World Health Organization (WHO).
Achieving Maturity Level 3 means Ethiopia has set up a strong regulatory system that meets international standards. This reinforces Ethiopia’s commitment to protecting public health. The recognition assures citizens, healthcare providers, and international partners that Ethiopia has the ability to regulate and monitor medicines effectively, ensuring their safety and quality for public use.
This milestone follows a thorough assessment done by WHO using its Global Benchmarking Tool (GBT), which evaluates regulatory authorities on a scale from one to four. Maturity Level 3 confirms that Ethiopia has a stable, well-functioning, and well-integrated regulatory system. This achievement reflects Ethiopia’s successful implementation of WHO recommendations and significant investment in improving pharmaceutical regulatory oversight.
“This achievement marks a historic moment for EFDA and Ethiopia’s healthcare sector,” said Heran Gerba, Director General of EFDA. “Attaining Maturity Level 3 is a testament to the Ethiopian government’s strong commitment to improving regulatory capacity and ensuring access to safe, effective, and high-quality medical products for everyone. It also shows the dedication of EFDA staff, stakeholders, and partners who have worked hard to strengthen our regulatory framework. Going forward, we will continue to improve and build on this success to better protect public health.”
The Director General noted that achieving Maturity Level 3 is a remarkable milestone for Ethiopia. It highlights the nation’s commitment to public health and strong regulations. She mentioned that this achievement represents a significant step toward building stronger, more resilient health systems that prioritize the safety, quality, and effectiveness of medical products.
Benefits of Achieving WHO Maturity Level 3
- Improved Public Health Protection
- International Recognition
- Better Access to Quality Medicines
- Stronger Local Pharmaceutical Sector
- Foundation for Regional and Global Collaboration
- Preparedness for Public Health Emergencies
- Capacity Building and Sustainability
- Pathway toward WHO Maturity Level 4
This milestone brings several strategic advantages, including:
- Strengthening public confidence in Ethiopia’s pharmaceutical regulatory system.
- Facilitating international cooperation and recognition among regulatory authorities.
- Enhancing the efficiency of regulatory processes to ensure timely access to safe, effective, and quality medicines.
- Supporting local pharmaceutical manufacturers in meeting global standards and improving competitiveness.
- Positioning EFDA for future eligibility as a WHO Listed Authority (WLA), further elevating Ethiopia’s role in global public health.
Ethiopia’s achievement of Maturity Level 3 is a significant step toward ongoing regulatory excellence. As Ethiopia continues to progress in healthcare and pharmaceutical development, it remains committed to maintaining the highest regulatory standards, ensuring that all medical products meet the required quality, safety, and effectiveness standards for the benefit of every Ethiopian.
The Ethiopian Food and Drug Authority (EFDA) achieved ML3 through an assessment finalized in September 2025.