The Ethiopian Food and Drug Authority (EFDA) officially launched the National Strategy for Combating Substandard and Falsified (SF) Medical Products (2026–2030) at a high-level event attended by senior government officials, regulatory bodies, and development partners. The launch featured remarks from EFDA Director General H.E. Ms. Heran Gerba and an opening address from Minister of Health H.E. Dr. Mekdes Daba, alongside contributions from the State Minister of Health, the Ministry of Justice, the Ethiopian Customs Commission, and other stakeholders.
Minister Dr. Mekdes emphasized the serious threat that substandard and falsified medical products pose globally and nationally, citing WHO data that at least one in ten medicines in low- and middle-income countries is substandard or falsified. She highlighted the impact of these products on treatment efficacy, morbidity, mortality, and antimicrobial resistance, underlining the importance of ensuring the supply of quality medicines to Ethiopia’s over 63 million health insurance beneficiaries. The country’s attainment of WHO Global Benchmarking Tool Maturity Level 3 (ML3) for medicines regulation was noted as a key step in strengthening regulatory oversight.
EFDA Director General H.E. Heran Gerba stressed that Ethiopia’s ML3 status reflects a stable and well-functioning regulatory system capable of preventing, detecting, and responding to substandard and falsified medical products. She outlined plans to advance to ML4 for medicines and ML3 for vaccines and medical devices, positioning EFDA as an African Centre of Excellence to further improve quality control, threat detection, and coordinated interventions across the supply chain.
The National Strategy for Combating SF Medical Products (2026–2030) establishes a comprehensive, multisectoral framework focused on prevention, detection, and response. The strategy aims to strengthen regulatory and legal frameworks, enhance surveillance and research, leverage digital technologies, build institutional and workforce capacity, raise public awareness, and reinforce national and international partnerships. Developed through extensive stakeholder consultations and supported by the Gates Foundation, it aligns Ethiopia’s priorities with global and regional regulatory initiatives.
A panel discussion at the event highlighted the responsibilities of EFDA, the Ethiopian Customs Commission, and the Ministry of Justice in combating SF medical products, emphasizing the importance of coordinated border control, market surveillance, information sharing, and legal enforcement. Panelists noted that increasingly sophisticated criminal networks involved in falsifying medical products require an intelligence-driven and coordinated regulatory response.
In closing, H.E. Heran reaffirmed EFDA’s commitment to implementing the strategy in collaboration with national and international partners, stressing the need for sustained partnerships, institutional accountability, and continued investment in regulatory capacity to ensure public trust in the safety and quality of medical products. The WHO also reiterated its support for Ethiopia in fully implementing the strategy, in line with global and regional efforts to strengthen regulatory systems and improve public health outcomes.
