Launch of Ethiopia’s National Strategy to Combat Substandard and Falsified Medical Products (2026-2030)

The Ethiopian Food and Drug Authority (EFDA) recently unveiled its comprehensive National Strategy aimed at tackling the pervasive issue of substandard and falsified (SF) medical products from 2026 to 2030. This significant event gathered top government officials, regulatory authorities, and key development partners to underscore the country’s commitment to safeguarding public health. EFDA Director General, H.E. Ms. Heran Gerba, opened the ceremony with welcoming remarks, followed by a keynote speech from H.E. Dr. Mekdes Daba, Ethiopia’s Minister of Health. The gathering also included H.E. Ms. Frehiwot Abebe, State Minister of Health, alongside representatives from the Ministry of Justice, Ethiopian Customs Commission, and other stakeholders.

Understanding the Threat: A National and Global Concern

Dr. Mekdes Daba emphasized the critical challenge posed by SF medical products, citing recent World Health Organization (WHO) data revealing that approximately 10% of medicines in low- and middle-income countries fail to meet quality standards. These compromised products not only jeopardize treatment outcomes but also escalate disease burden and mortality rates, while accelerating antimicrobial resistance-a growing global health crisis. For Ethiopia, where over 63 million people now benefit from health insurance coverage, ensuring access to safe, effective, and quality-assured medicines is a cornerstone of national health policy.

Regulatory Milestones and Future Aspirations

Highlighting Ethiopia’s progress, EFDA Director General Heran Gerba noted the country’s recent achievement of WHO’s Global Benchmarking Tool (GBT) Maturity Level 3 (ML3) for medicines regulation. This designation reflects a robust, integrated regulatory system capable of consistently executing all essential functions to prevent and manage SF medical products throughout their lifecycle. Ms. Gerba outlined ambitions to elevate Ethiopia’s regulatory framework further by attaining ML4 status for medicines and ML3 for vaccines and medical devices. These advancements aim to position EFDA as a leading African Centre of Excellence, enhancing rapid threat detection, stringent quality assurance, and coordinated interventions across the pharmaceutical supply chain.

Strategic Pillars: Prevention, Detection, and Response

The newly launched National Strategy adopts a holistic, multisectoral approach structured around three core pillars: prevention, detection, and response. Key focus areas include:

• Strengthening legal and regulatory frameworks to close existing gaps
• Enhancing surveillance systems and research capabilities to identify and monitor SF products
• Leveraging digital technologies and innovative tools for real-time tracking and data sharing
• Building institutional capacity and workforce expertise to sustain regulatory functions
• Raising public awareness to empower consumers and healthcare providers
• Fostering national and international collaborations to harmonize efforts and share intelligence

Developed through extensive consultations with stakeholders and supported by the Bill & Melinda Gates Foundation, the strategy aligns Ethiopia’s priorities with global and regional regulatory frameworks, reinforcing the country’s commitment to international best practices.

Collaborative Enforcement: A Unified Front Against Criminal Networks

A panel discussion involving EFDA, the Ethiopian Customs Commission, and the Ministry of Justice highlighted the critical roles each sector plays in combating SF medical products. The dialogue underscored the necessity of synchronized border controls, vigilant market surveillance, timely information exchange, and rigorous legal enforcement. Given the increasing sophistication of criminal enterprises involved in counterfeit pharmaceuticals, the panel stressed the importance of intelligence-led, coordinated regulatory and law enforcement responses to dismantle these networks effectively.

Commitment to Implementation and Global Support

Concluding the event, H.E. Ms. Heran Gerba reaffirmed EFDA’s dedication to spearheading the strategy’s execution in partnership with both domestic and international stakeholders. She emphasized the need for sustained collaboration, institutional accountability, and ongoing investment in regulatory infrastructure to maintain public confidence in the safety and quality of medical products circulating in Ethiopia.

The World Health Organization reiterated its pledge to assist Ethiopia in fully operationalizing this strategy, aligning efforts with global and regional initiatives aimed at eradicating substandard and falsified medical products and strengthening regulatory systems to improve health outcomes.

Addressing Maternal Mortality in the Central African Republic: A Path Toward Safer Motherhood

Bangui- The Central African Republic (CAR) continues to grapple with one of the world’s most alarming maternal mortality rates, with 829 maternal deaths per 100,000 live births reported in 2023. This stark figure reflects the harsh realities faced by many women, including limited access to healthcare facilities, long travel distances, scarce medical resources, and cultural barriers that often prevent timely care.

Challenges in Maternal Health Access and Care

Less than half of expectant mothers in CAR complete the recommended four antenatal visits, and nearly 30% of births still occur at home without skilled assistance. These conditions significantly increase the risk of complications for both mothers and newborns, as highlighted by recent national health data.

Geographical isolation and infrastructural deficits exacerbate these challenges, especially in rural regions where health centers are few and far between. Additionally, traditional beliefs and misinformation sometimes discourage women from seeking professional medical support during pregnancy and childbirth.

Strategic Focus on Universal Health Coverage to Reduce Maternal Deaths

In response, the government of CAR has prioritized universal health coverage (UHC) to ensure that every woman receives quality maternal care without financial hardship. The national strategy emphasizes essential services such as antenatal care, skilled birth attendance, and effective management of pregnancy-related complications, all accessible regardless of economic status.

This approach not only aims to prevent avoidable maternal deaths but also fosters trust in the healthcare system, encouraging more women to utilize available services and improving overall community health outcomes.

Empowering Communities Through Midwifery

With support from the World Health Organization (WHO) and international donors, CAR has implemented a robust program to train and deploy community midwives. These midwives, selected by their own communities, serve as crucial intermediaries between families and health facilities. They provide education, guidance, and accompaniment throughout pregnancy, delivery, and postpartum care.

By promoting the importance of antenatal visits and skilled delivery, community midwives help shift cultural perceptions and reduce home births, which are often associated with higher risks. Their presence reassures families and strengthens the continuum of care.

Erguine Souhat, a midwife based in Bria, shares, “There was a night when I had to escort a woman to the hospital on foot, prepared to assist her en route if needed. We support women from early pregnancy through the postpartum period to ensure both mother and child remain healthy.”

Government Commitment and Measurable Progress

Dr. Romaric Ghislain Zarambaud Bohy-Ngombet, Director of Family Health and Population at the Ministry of Health, emphasizes the urgency: “Maternal mortality is a national crisis. Our Minister of Health has outlined a clear plan: enhance healthcare providers’ skills, upgrade medical infrastructure, and extend services closer to communities. This is the foundation for achieving universal health coverage.”

Currently, over 1,200 active midwives operate across 32 of the country’s 35 health districts, predominantly in underserved rural areas. According to Dan Mauricette, National Coordinator of Community Midwives, “Where midwives are deployed, home births have decreased by approximately 30%, and antenatal care attendance has risen significantly.”

Recent Investments and Training Initiatives

In 2024, WHO facilitated the equipping of around 30 maternity wards with essential medical supplies and medications, enhancing the safety and dignity of childbirth services. Additionally, 300 community midwives received comprehensive training in prenatal, delivery, and postpartum care, including referral protocols. Sixty-four healthcare workers were also trained to identify gynecological risks, further improving the quality of maternal health services.

Dr. Caroline Clarinval, WHO Representative in CAR, states, “Every maternity ward equipped and every midwife trained represents a life saved. Our mission is clear: to ensure that every woman, regardless of location, can experience a safe childbirth. Achieving this requires tailored clinical guidelines, ongoing capacity building, and sustained community engagement.”

Transforming Lives: Stories of Hope and Survival

These efforts are making a tangible difference. Albertine Shoura, a mother of three, recounts her experience: “I once gave birth at home and nearly lost both my baby and myself. Thanks to Erguine’s support, I was able to deliver safely in a hospital with proper care. I am deeply grateful to her and to God for saving our lives.”

Albertine reflects on the broader impact: “When a mother and child survive, hope is restored for the entire family. I wish every woman in our country could have this opportunity, so that childbirth becomes a moment of joy rather than danger.”

Renewed Commitment to Combat Diphtheria Across African Nations

Brazzaville – Amid a troubling resurgence of diphtheria affecting eight African Member States, health ministers have reaffirmed their dedication to eradicating this entirely vaccine-preventable disease. This renewed political will aims to curb the spread and protect vulnerable populations through strengthened immunization efforts.

High-Level Advocacy Meeting Spurs Unified Action

Convened by Dr. Mohamed Janabi, WHO Regional Director for Africa, a strategic meeting gathered Ministers of Health and senior officials from Chad, Guinea, Mali, Mauritania, Niger, Nigeria, and South Africa-countries currently grappling with diphtheria outbreaks. Key partners such as UNICEF, GAVI, the Vaccine Alliance, and Africa CDC also participated, emphasizing a collaborative approach to tackling the crisis.

Addressing Immunization Gaps and Strengthening Health Systems

More than 90% of diphtheria cases have been reported among children who are either unvaccinated or inadequately immunized, underscoring persistent deficiencies in routine vaccination coverage and access to essential healthcare services. Dr. Janabi highlighted, “With the vaccines and expertise available today, the scale of this outbreak is unacceptable. No child should succumb to a preventable illness.”

WHO continues to assist Member States by enhancing disease surveillance, facilitating laboratory confirmations, improving clinical care, coordinating vaccination campaigns, and managing the distribution of limited diphtheria antitoxin (DAT) supplies. Nonetheless, challenges such as insufficient funding, limited laboratory infrastructure, delayed case detection, and restricted access to DAT and antibiotics hinder progress.

Systemic Challenges Amplify Diphtheria’s Impact

The resurgence of diphtheria reflects deeper systemic weaknesses, including stagnant immunization rates and fragile primary healthcare frameworks exacerbated by the COVID-19 pandemic’s aftermath. In regions affected by conflict and displacement, insecurity and disrupted health services further impede timely diagnosis and treatment, allowing outbreaks to escalate unchecked.

Dr. Jean Kaseya, Director General of Africa CDC, emphasized the importance of community involvement and local vaccine production, stating, “Empowering communities and expanding Africa’s vaccine manufacturing capacity are vital steps toward resilient immunization programs and robust primary healthcare.”

Strategic Priorities and Collaborative Solutions

Participants exchanged insights on country-specific experiences and identified critical obstacles requiring sustained political and financial commitment. Key priorities include:

• Implementing large-scale catch-up vaccination campaigns to close immunity gaps
• Enhancing surveillance systems and laboratory capabilities for prompt outbreak detection
• Improving clinical management protocols to reduce mortality rates
• Ensuring consistent availability of essential medicines, including DAT and antibiotics

Minister Mohamed Mahmoud Ely Mahmoud of Mauritania expressed gratitude for the ongoing support from WHO, Africa CDC, and partners, emphasizing the necessity of coordinated efforts to protect vulnerable populations through timely detection and response.

A Call to Action: Prioritizing Diphtheria Elimination

The meeting concluded with a resolute appeal from Dr. Janabi for all governments to prioritize diphtheria elimination. He stressed that safeguarding every child and community from vaccine-preventable diseases is achievable through decisive measures to bolster surveillance, expand immunization coverage, and ensure rapid outbreak response across the continent.

Current Context and Future Outlook

Recent WHO data indicates that while global diphtheria cases have declined over the past decade, localized outbreaks in Africa highlight the urgent need for renewed focus on immunization equity. For example, Nigeria reported a 15% increase in diphtheria cases in 2023 compared to the previous year, underscoring the fragility of health systems in certain regions.

Innovative approaches, such as mobile vaccination clinics and community health worker engagement, are being piloted to reach remote and conflict-affected populations. These efforts, combined with increased investment in local vaccine production facilities, aim to create sustainable solutions that will prevent future outbreaks and save lives.