Ethiopia Unveils Comprehensive Plan to Tackle Substandard and Falsified Medical Products (2026-2030)
In a significant step towards safeguarding public health, Ethiopia's Ethiopian Food and Drug Authority (EFDA) has launched a national strategy to combat substandard and falsified medical products for the period 2026-2030. This ambitious initiative was unveiled at a high-profile event, attended by prominent government officials and key stakeholders, underscoring the nation's commitment to addressing a critical global health challenge.
The ceremony commenced with welcoming remarks from H.E. Ms. Heran Gerba, EFDA Director General, followed by an opening address by H.E. Dr. Mekdes Daba, Minister of Health. The event also featured H.E. Ms. Frehiwot Abebe, State Minister of Health, along with representatives from various ministries, regulatory bodies, and development partners, all united in their dedication to tackling this pressing issue.
Dr. Mekdes Daba, in her address, highlighted the global and national threat posed by substandard and falsified medical products. She cited World Health Organization (WHO) data, revealing that a staggering one in ten medicines in low- and middle-income countries is substandard or falsified. Dr. Daba emphasized that these substandard products undermine treatment effectiveness, increase morbidity and mortality rates, and contribute to the alarming issue of antimicrobial resistance. This, she stressed, poses a significant public health and development challenge for Ethiopia.
"With over 63 million citizens now covered by health insurance, ensuring the supply of quality, proven, and effective medical products is a top priority for our healthcare policies," Dr. Daba stated. She further noted that Ethiopia's regulatory response has been bolstered by the country's recent achievement of WHO Global Benchmarking Tool (GBT) Maturity Level 3 (ML3) for medicines regulation. This milestone signifies a robust, well-functioning, and integrated regulatory system capable of reliably performing all core functions.
H.E. Ms. Heran Gerba emphasized that Ethiopia's ML3 status is a testament to the country's ability to effectively prevent, detect, and respond to substandard and falsified medical products throughout their lifecycle. She highlighted that advancing to ML4 for medicines, ML3 for vaccines and medical devices, and positioning EFDA as an African Centre of Excellence will further enhance oversight. This will enable faster threat detection, stricter quality control, and more coordinated interventions across the entire supply chain.
The National Strategy for Combating Substandard and Falsified Medical Products (2026-2030) is a comprehensive, multisectoral framework built on the pillars of prevention, detection, and response. It focuses on strengthening regulatory and legal frameworks, enhancing prevention, detection, and response mechanisms, strengthening surveillance and research, leveraging digital technologies and innovation, building institutional and workforce capacity, raising public awareness, and reinforcing national and international partnerships. This strategy was developed through extensive stakeholder consultation and is supported by the Gates Foundation, aligning Ethiopia's priorities with global and regional regulatory initiatives.
A panel discussion featuring EFDA, the Ethiopian Customs Commission, and the Ministry of Justice shed light on sector-specific mandates and shared responsibilities in the prevention, detection, and response to substandard and falsified medical products. The discussion emphasized the critical role of coordinated border control, market surveillance, information sharing, and effective legal enforcement. It also highlighted the need for an equally coordinated and intelligence-driven regulatory and enforcement response to combat increasingly sophisticated criminal networks involved in falsifying medical products.
In her closing remarks, H.E. Heran Gerba reaffirmed EFDA's commitment to leading the strategy's implementation in collaboration with national and international stakeholders. She emphasized the importance of sustained partnerships, institutional accountability, and continued investment in regulatory capacity to ensure public trust in the safety and quality of medical products. The World Health Organization (WHO) has reiterated its commitment to supporting Ethiopia in fully implementing this strategy, aligning with global and regional efforts to combat substandard and falsified medical products and strengthen regulatory systems for improved public health outcomes.
