October 3, 2025 Sao Tome): The IGAD Secretariat in collaboration with the African Union Development Agency (AUDA-NEPAD)’s African Medicines Regulatory Harmonisation (AMRH) program and the Economic Community of Central Africa States (ECCAS), conducted a technical support and advocacy mission in Sao Tome and Principe on Strengthening Medicines Regulatory Systems, under the World Bank-funded Health Emergency Preparedness, Response, and Resilience Programme (HEPRRP) for East and Southern Africa.
This mission conducted from 23rd September to October 2, 2025, in Sao Tome, involved advocacy and technical engagement with the Ministry of Health leadership, led by the Minister of Health, Department of pharmacy experts, key government agencies, the pharmaceutical association, private sector actors, and technical partners from IGAD, AUDA-NEPAD, ECCAS, and Organization for the Fight against Endemic Diseases in Central Africa (OCEAC)
The mission focused on supporting the Government of São Tomé and Príncipe (STP) in laying the foundation for the operationalization of the National Medicines Regulatory Authority (ARFAMED), aligning STP’s medicines legal framework with the African Union’s Model Law on Medicines Regulation, and advocating for the ratification of the African Medicines Agency (AMA) Treaty – aiming to ensure access to quality, safe and effective products by the population.
Lifesaving Medicines and health products for Effective preparedness and response to Health Emergencies
The IGAD Secretariat, in collaboration with the East, Central and Southern Africa Health Community (ECSA-HC) is implementing the regional component of the World Bank-funded Health Emergency Preparedness, Response, and Resilience Programme – Multi-Phase Programmatic Approach Program (HEPRR-MPA), where Sao Tome and Principe is one of the participating countries.
The Program’s development objective is to strengthen the health system’s resilience and multi-sectoral preparedness and response to public health emergencies in the region and across the continent.
IGAD is spearheading the program’s sub-component that focuses on supporting access to quality-assured health products and technologies, including capacity building for the local production of vaccines and pharmaceuticals in participating Countries.
Sao Tome and Principe, which solely relies on imported medicines, vaccines, and other health products, was placed at Maturity Level One (ML1) by the World Health Organization’s Global Benchmarking Tool (GBT) self-assessment that was conducted in 2022.
Since then, steady efforts have been made to implement institutional development plans, strengthen pharmacovigilance, regulate clinical trials, and prepare the statutes necessary for the establishment of ARFAMED. These foundations are essential for the journey toward Maturity Level Three (ML3), the threshold of a stable, integrated, and effective national regulatory system. Implementation of effective legal and regulatory frameworks is the foundation of mature NRAs.
Calls for Effective Regulatory Systems
Attending the sessions, the Minister of Health for Sao Tome and Principe, Hon. Dr. Celso Matos, stated that producing medicines within Africa is essential for addressing health emergencies, emphasizing the need to strengthen human resources and develop local industrial capacity to meet population needs.
Dr. Celso noted that ensuring a sustainable health system is, therefore, a major priority.
“One of the main concerns today is the production of medicines on our continent and how we can better prepare our countries for possible emergencies, which requires not only strengthening our human resources but also developing our own industrial capacity to truly respond to the needs of our populations,” said Dr. Celso.
The Head of Health Unit at the IGAD Secretariat, Dr. Mohammed Elduma, affirmed IGAD’s continued collaboration with the STP Ministry of Health to provide technical assistance in strengthening medicines regulation, manufacturing, logistical, and supply systems.
Technical experts from AUDA-NEPAD, ECCAS and OCEAC took the participants through the regional and continental legal and regulatory frameworks, including the African Union Model Law on Medical Products Regulation and the African Medicines Agency (AMA) treaty.
Dr. Nancy Ngum, AMRH’s Programme Officer, urged STP to accelerate the domestication of the AU Model Law, emphasising that this step would be ‘a critical enabler for building a cohesive regulatory ecosystem, fostering alignment, and facilitating effective engagement in both regional initiatives and the AMA.’
Dr. Peggy Raymonde Conjugo-Batoma, Head of the Health Department at ECCAS, emphasized the need to strengthen medicines regulatory systems, noting that this would help address interrupted supply chains, price fluctuations, and the circulation of substandard and falsified (SF) medical products that have plagued the region.
Session Outcomes
The key outputs from the mission include a comprehensive review and amendments to the provisions of the draft Decree Law for establishment of ARFAMED and the other decree laws on regulation of medicines and health products across the various regulatory functions to align with the AU Model Law on the regulation of medical products.
These include; market authorization and registration, regulatory inspections and market surveillance and control, vigilance and safety monitoring, control of clinical trials, licensing of establishments and laboratory testing and lot release. The engagement also provided an advocacy platform for the ratification of the AMA Treaty.
Participants recommended that the Government of STP establish a national multi-sectoral committee to combat substandard and falsified medical products and conduct a national quality survey of medicines to determine the prevalence of substandard and falsified medicines in the country, among others.
