West African countries are intensifying efforts to strengthen regional regulatory frameworks as part of a broader strategy to accelerate biomanufacturing and reduce heavy dependence on imported vaccines. This was a central theme at the West Africa Bio-manufacturing Regulation and Market Access Conference held in Accra, where policymakers, regulators, and industry stakeholders emphasized the urgent need for coordinated action to unlock local vaccine production, biologics development, and biotechnology innovation across the sub-region.
Speaking at the conference, Director-General of the African Medicines Agency, Delese Darko, highlighted that West Africa already has a solid foundation to build upon. She explained that the region has made significant progress in harmonising regulatory systems for medicines, agriculture, and biosafety, which can now be extended to support the growth of biomanufacturing. According to her, this existing alignment provides a critical advantage in ensuring that vaccines and biologics produced in one country can be approved and distributed across multiple countries without unnecessary delays.
Dr. Darko stressed that regional integration is essential for achieving Africa’s ambitious goal of producing 60% of its vaccines locally by 2040. She warned that the continent’s current reliance on importing up to 99% of its vaccines exposes it to serious risks, including supply chain disruptions, global shortages, and vulnerabilities during health emergencies. Strengthening local manufacturing capacity, she noted, is therefore not only an economic priority but also a matter of public health security.
Experts at the conference outlined a “regional-first, national-implementation” approach as a practical model for advancing biomanufacturing. Under this framework, ECOWAS provides overarching policy direction, while the West African Health Organization (WAHO) leads technical coordination and regulatory alignment among member states. This structure is designed to ensure consistency in standards while allowing individual countries to implement policies within their national contexts.
Participants pointed to the West Africa Medicines Regulatory Harmonisation (WA-MRH) initiative as a successful example of regional cooperation. The programme has established a centralized system for approving medicines and vaccines across 15 West African countries, significantly reducing duplication and speeding up regulatory processes. Building on this model, stakeholders are now working to extend harmonisation into biomanufacturing, covering critical areas such as Good Manufacturing Practice (GMP), clinical trial oversight, pharmacovigilance, and biosafety regulations.
In the context of biomanufacturing, these regulatory efforts also encompass advanced and emerging technologies, including cell and gene therapies, bioprocess validation, and laboratory quality assurance systems. Stakeholders emphasized that harmonized standards in these areas are essential for ensuring product safety, quality, and international competitiveness.
Another key focus is the adoption of joint regulatory assessment mechanisms, which allow multiple countries to rely on a single scientific evaluation when approving vaccines and biologics. This approach reduces redundancy, lowers costs, and accelerates market access across borders. At the same time, regional policies are being aligned to support research and development, technology transfer, and intellectual property protection—factors considered crucial for building sustainable local manufacturing ecosystems.
These West African initiatives are also being linked to broader continental programmes such as the African Medicines Regulatory Harmonisation (AMRH) initiative and the operationalisation of the African Medicines Agency. The long-term objective is to establish a unified African regulatory system that facilitates the free movement of pharmaceutical products while maintaining high safety and quality standards.
Despite the progress, several challenges continue to hinder the pace of development. Chief Executive Officer of the National Vaccine Institute, Sodzi Sodzi-Tettey, identified fragmented legal frameworks, language barriers, limited infrastructure, and delays in adopting regional protocols as major obstacles. These issues, he noted, complicate coordination and slow down the implementation of harmonized systems.
Similarly, Director of Pharmaceutical Services at the Ministry of Health, Saviour Yevutse, called for stronger political commitment to meet the 2040 vaccine production target. He warned that Africa’s continued dependence on imports leaves the region exposed to global supply shocks and undermines efforts to achieve health security.
He stressed the need to move beyond policy discussions to concrete implementation, particularly in areas such as pooled procurement and market access. According to him, vaccines and biopharmaceuticals produced within the region must be able to circulate freely without regulatory bottlenecks. He emphasized that a product manufactured in one West African country should be readily accepted in another, eliminating unnecessary delays and duplication.
Participants at the conference collectively called for increased investment in infrastructure, capacity building for regulatory institutions, and the development of integrated procurement systems. They argued that sustained political will, combined with strong institutional coordination and private sector participation, will be essential to position West Africa’s biomanufacturing sector as competitive within the global pharmaceutical value chain.
Overall, the conference underscored a growing consensus that regional collaboration and regulatory harmonisation are key to transforming West Africa into a hub for vaccine production and biotechnology innovation, ultimately reducing dependence on imports and strengthening the region’s resilience to future health crises.
