Addis Ababa, September 30, 2025 (FMC) — Ethiopia has crossed a pivotal threshold in health governance after the World Health Organization (WHO) formally recognized its national medicines regulatory system as meeting Maturity Level 3 (ML3). The announcement was included in a WHO statement issued Tuesday.
The distinction places Ethiopia among just nine African countries to reach this benchmark, joining Egypt, Ghana, Nigeria, South Africa, Tanzania, Zimbabwe, Senegal, and Rwanda.
According to the WHO, a regulatory system at ML3 is “stable, well-functioning, and integrated,” capable of carrying out essential functions such as product authorization, post-market surveillance, and safety event management.
The highest standard, Maturity Level 4, is reserved for systems with advanced, continuously improving functions.
The Ethiopian Food and Drug Authority (EFDA) was credited for its sustained reforms and capacity building, which enabled the country to meet more than 250 global benchmarking indicators evaluated by WHO.
Ethiopia’s Health Minister, Dr. Mekdes Daba, described the milestone as more than a technical achievement, emphasizing its impact on public confidence and health system resilience.
“It gives me great pleasure to share that Ethiopia has achieved Maturity Level 3 in medicines regulation, as recognized by the World Health Organization. This milestone strengthens our ability to respond to health threats and brings us closer to the resilient health system our communities deserve,” she said.
Dr. Mekdes also highlighted the milestone’s alignment with Ethiopia’s strategy for local production of medicines and vaccines, ensuring sustainable access and self-reliance.
“This achievement is a testament to the collective action and hard work of EFDA and our partners, who together have strengthened the systems that guarantee the quality, safety, and effectiveness of medical products in our country,” she added.
She concluded by reaffirming the government’s commitment to building on the progress, stating that Ethiopia will continue to enhance its regulatory systems to safeguard public health and wellbeing.
WHO Regional Director for Africa, Dr. Mohamed Yakub Janabi, described Ethiopia’s achievement as “a landmark moment not only for the country but for Africa as a whole,” emphasizing that strong regulatory systems enhance public trust in medicines and support universal health coverage.
WHO Assistant Director-General for Health Systems, Access and Data, Dr. Yukiko Nakatani, added that the milestone demonstrates Ethiopia’s leadership and commitment to protecting its population while contributing to global efforts for access to quality-assured medical products.
The WHO said the assessment in Ethiopia was finalized in September 2025.