July 26, 2026 (MOMBASA, Kenya): Experts from Ministries of Health, National Medicines Regulatory Authorities (NRAs), National Quality Control Laboratories (NQCLs), vaccines and other health products manufacturers, central procurement agencies, Regional Economic Communities (RECs), Africa Union Agencies, academia and research institutions, technical and development partners from Eastern and Southern Africa have agreed on a regional roadmap to accelerate local manufacturing of health products and technologies, reaffirming a shared commitment to strengthening Africa’s health security and reducing dependence on imported Health products and technologies
The Community of Practice (COP) meeting, convened by the IGAD Secretariat under the Health Emergency, Preparedness, Response and Resilience Programme (HEPRRP), brought together delegates from nine of the eleven participating countries: including Burundi, the Democratic Republic of Congo, Ethiopia, Kenya, Malawi, Mozambique, Rwanda, Sao Tome & Principe, and Zambia.
The meeting focused on reviewing progress, sharing country experiences, and identifying practical actions to strengthen pharmaceutical manufacturing, improve regulatory systems, and expand access to quality-assured medicines and health technologies across the region.
Dr. Mohamed Elduma, Head of the Health Unit at the IGAD Secretariat, representing the Director of Health and Social Development, said the initiative aims to strengthen resilient national and regional manufacturing ecosystems to boost the local production, regulation, and equitable access to quality-assured safe and effective health products by the population.
“Local manufacturing is not merely an economic opportunity but a public health necessity and a strategic investment in collective health security,” Dr. Elduma said, noting that the COVID-19 pandemic exposed vulnerabilities in regional supply chains and highlighted the urgent need for stronger domestic production capacity.
Representatives from the East African Community (EAC), the Common Market for Eastern and Southern Africa (COMESA), Africa CDC, AUDA-NEPAD, and the World Health Organization (WHO) also shared updates on regional initiatives supporting local manufacturing, regulatory harmonisation, and pharmaceutical development at regional and continental levels.
Dr. Tina Chisenga, representing the East, Central and Southern Africa Health Community (ECSA-HC), emphasized that continued dependence on external supply chains leaves countries vulnerable, especially during public health emergencies.
She noted that strengthening local manufacturing is critical to improving supply resilience, reducing lead times, and ensuring sustained access to essential health commodities when crises arise.
A key message reaffirmed during the meeting is the continental ambition to increase local production from its current level of approximately 1% to 60% of Africa’s vaccine and essential health product needs by 2040. The goal is aimed at positioning the continent to better respond to future health emergencies while strengthening healthcare self-reliance.
Dr. Ramesh Govindaraj, Lead Specialist for the Health, Nutrition and Population Global Practice at the World Bank, underscored the importance of strengthening local pharmaceutical production as a cornerstone of Africa’s health security agenda.
“Local manufacturing is central to realising that vision,” he said. “Self-reliance is not about isolation; it is about building strong regional capabilities, trusted institutions, and sustainable partnerships that ensure Africa can respond effectively to its own health priorities.”
Tackling Bioequivalence Testing Gaps and Regulatory Compliance Challenges
The meeting held a detailed discussion focused on addressing technical bottlenecks that have historically limited the growth of Africa’s pharmaceutical manufacturing sector, particularly compliance with current Good Manufacturing Practices (cGMP) and the high costs associated with Bioequivalence (BE) studies required for market authorisation and registration requirements for medicinal products. .
In order to address the persistent bottlenecks for the local health manufacturers, the experts recommended adopting risk-based regulatory approaches in implementing the Bioequivalence/Biowaiver requirements based on the World Health Organization-recommended Biopharmaceutics Classification System (BCS) establishing and operationalising accredited regional Bioequivalence centers, and increasing direct financial and technical support for local manufacturers of BE eligible medicinal products
The National Medicines Regulatory Authorities (NRAs) reviewed progress on implementation of the GMP roadmaps in the MPA participating countries. Delegates emphasised that sustained political commitment, strong regulatory institutions, and industry ownership remain critical to achieving internationally recognised manufacturing standards by the local manufacturers of health products
They also acknowledged continuing challenges, including global supply chain disruptions, financing constraints, and the loss of skilled technical personnel during institutional transitions.
To advance these efforts, participants agreed to jointly develop a regional White Paper on Bioequivalence implementation alongside a practical regulatory framework to guide manufacturers and regulators in achieving regulatory compliance across participating countries.
Strengthening Supply Chain Resilience
Beyond regulatory standards, the experts explored broader strategies for strengthening local pharmaceutical health manufacturing through enhanced collaboration, resilient supply chains, and coordinated investments.
Participants emphasised that sustainable manufacturing ecosystems require synchronised action across governments, regulators, manufacturers, development partners, academia, and the private sector.
Key updates were presented on major continental initiatives, including the Africa Initiative for Medical Access and Manufacturing (AIM 2030) by the World Bank, the Africa Pool Procurement Mechanism (APPM), the Platform of Africa Vaccines Manufacturing (PAVM), Platform for Harmonised African Health Products Manufacturing (PHAHM) which are currently being operationalised by Africa CDC. These initiatives are designed to aggregate regional demand, strengthen African pharmaceutical markets, and provide manufacturers with the market certainty needed to support long-term investments.
CoP Reviews Progress on Local Manufacturing
The participants were updated on the milestones achieved by the Community of Practice (CoP) on local health manufacturing through regional cooperation and collaboration, including the development of harmonised GMP inspection templates, technical support for strengthening Sao Tome & Principe’s legal framework on regulation of medicines and health products, as well as development of the regional framework on regulatory reliance
Looking ahead, delegates endorsed several immediate actions to sustain momentum. These include expanding joint GMP inspections across Zambia, Kenya, and Ethiopia, strengthening capacity in intellectual property management and technology transfer, establishing regional center of excellence for quality control of health products and technologies, and creating a centralised digital knowledge hub to facilitate information sharing and collaboration among member states.
Participants also committed to conducting regional surveys to identify supply gaps, monitor substandard imported medicines, and support evidence-based planning for pharmaceutical manufacturing across the region.
Key Lessons: Market Certainty, Regulatory Maturity & Harmonisation
Discussions underscored that technical improvements alone will not sustain local pharmaceutical industries without strong policy support and predictable markets Delegates agreed that preferential procurement policies, multi-year framework agreements of five to seven years, and coordinated regional purchasing mechanisms are essential to providing manufacturers with the confidence to invest in production capacity.
Country experiences, including Ethiopia’s National Multi-Stakeholder Platform for Local Manufacturing (LoPID) and Kenya’s market-shaping initiatives, demonstrated how coordinated engagement between health, trade, and industry sectors can accelerate local manufacturing.
Participants further emphasised that regulatory harmonisation and achieving higher levels of maturity based on the World Health Organization Global Benchmarking Tool (WHO GBT) will strengthen investor confidence, improve market integration, and facilitate access to quality-assured medicines throughout the region.
Recommendations and Strategic Roadmap
To overcome persistent technical and economic barriers, the Community of Practice recommended developing a regional White Paper on Bioequivalence implementation, and establishing accredited regional Bioavailability and Bioequivalence (BA/BE) centers supported through phased implementation and targeted subsidies for legacy products.
Delegates also called on member states to strengthen industrial financing by reducing taxes on pharmaceutical raw materials, introducing longer-term procurement agreements, and leveraging regional market integration and pooled procurement mechanisms to create sustainable demand for locally manufactured products.
To build long-term manufacturing capacity and safeguard regional health security, participants recommended creating a regional pool of GMP experts, institutionalising centers of excellence, expanding joint GMP inspections, and strengthening technical cooperation among participating countries.
The meeting concluded with a renewed commitment to establish a centralised digital knowledge hub, generate shared knowledge products, strengthen peer-to-peer learning, and enhance accountability across member states.
Participants also agreed to officially rename the initiative as the Community of Practice on Regional Manufacturing of Health Products and Technologies, reflecting its broader regional mandate and long-term vision of advancing healthcare self-reliance across Eastern and Southern Africa
