The Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has officially called upon international development partners and global health stakeholders to provide the technical and financial support necessary to establish a localized, modular vaccine manufacturing facility in Nigeria. This appeal, delivered at the 8th Nigeria Pharma Manufacturers Expo held in collaboration with the Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMG-MAN) and PGE Expo PVT Limited, marks a critical turning point in the nation’s quest for pharmaceutical sovereignty and WHO regulatory excellence.
The Strategic Imperative for Vaccine Lot Release
At the core of Prof. Adeyeye’s address was the missing link in Nigeria’s regulatory evolution: the capacity for "Vaccine Lot Release." While NAFDAC has successfully met the rigorous requirements for eight out of the nine functional areas mandated by the World Health Organization (WHO) for regulatory oversight of medicines and vaccines, the absence of a domestic fill-and-finish facility remains the primary obstacle to achieving WHO Maturity Level 4 status.
Maturity Level 4 is the gold standard for national regulatory authorities, signifying that an agency operates at an advanced level of performance and can provide continuous improvement. Achieving this would not only validate Nigeria’s regulatory framework but also allow the nation to function as a regional hub for vaccine distribution and quality control. Prof. Adeyeye emphasized that the investment required to bridge this gap is relatively modest, and the agency is prepared to present detailed cost-benefit analyses to prospective partners to ensure the project’s immediate viability.
A Chronology of Regulatory Advancement
To understand the significance of this request, one must look at the timeline of NAFDAC’s recent progress. Following the achievement of WHO Maturity Level 3 in 2022—which confirmed that the agency had a stable, well-functioning, and integrated regulatory system—NAFDAC has been on a trajectory of aggressive reform.
In 2023, the agency achieved a major milestone by becoming a member of the International Medical Device Regulators Forum (IMDRF), an elite global group of medical device regulators. That same year, in September, the NAFDAC Central Drug Control Laboratory in Yaba, Lagos, received WHO prequalification, marking it as a world-class facility capable of testing and certifying pharmaceutical products to international standards.
Most recently, NAFDAC became the first regulatory agency in sub-Saharan Africa to undergo a successful re-benchmarking process following its initial Maturity Level 3 certification. This sustained effort reflects a deliberate strategy to move beyond basic oversight toward international standard-setting. The push for a vaccine facility is the natural next step in this multi-year roadmap.
Strengthening Good Manufacturing Practices
The call for localized production is supported by a broader, data-driven transformation of Nigeria’s domestic pharmaceutical industry. Under the NAFDAC GMP (Good Manufacturing Practice) Roadmap initiative—funded by USAID and implemented by the United States Pharmacopoeia—the agency has conducted rigorous audits across the country. Over an eight-month period, inspectors evaluated more than 165 pharmaceutical companies to ensure they adhere to strict international quality standards.
The impact of these regulatory interventions is quantifiable. Statistical data covering the period from 2021 to 2025 indicates that imports of pharmaceutical products categorized under the "5 plus 5" and Ceiling Initiative have plummeted by approximately 70 percent. This shift is not merely a result of trade policy but a reflection of increased domestic production capacity. As local manufacturers have improved their compliance, they have effectively captured market share that was previously dominated by foreign imports, thereby enhancing the security of the domestic drug supply chain.
Industry Perspective: The PMG-MAN Stance
The 8th Nigeria Pharma Manufacturers Expo served as a vital forum for these discussions, drawing 132 participating companies from across the globe, including representatives from the United States, China, Egypt, India, Rwanda, and several European nations.
Mr. Oluwatosin Jolayemi, Chairman of the Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMG-MAN), echoed the urgency of the moment. During his keynote, he lauded the regulatory reforms led by Prof. Adeyeye, noting that the "5 plus 5" policy and enhanced GMP compliance have fundamentally altered the landscape of the local industry. However, Jolayemi cautioned that these gains are fragile.
To ensure long-term stability, he formally advocated for the extension of the Federal Government’s Executive Order on pharmaceutical manufacturing incentives. With the current order set to expire in March 2027, the industry is calling for a two-year extension to provide the policy certainty required for long-term capital investment. According to industry leaders, medicine security is not achieved through short-term interventions but through consistent, predictable regulatory and fiscal environments that encourage manufacturers to invest in high-tech infrastructure, such as the vaccine facilities proposed by NAFDAC.
Socio-Economic Implications and Global Health Security
The implications of establishing a modular vaccine manufacturing facility in Nigeria extend far beyond national borders. For Nigeria, the most populous country in Africa, the ability to produce vaccines locally is a matter of national health security. The lessons of the COVID-19 pandemic underscored the dangers of over-reliance on international supply chains, which often left developing nations at the back of the queue for life-saving immunizations.
From an economic perspective, domestic production reduces the heavy burden of foreign exchange expenditure on imported pharmaceuticals. By shifting from an import-dependent model to a manufacturing-led model, Nigeria can stimulate industrial growth, create highly skilled jobs for pharmacists and biochemical engineers, and foster a more robust biotechnology sector.
Furthermore, a regional vaccine hub in Nigeria could serve the West African sub-region, providing a reliable supply of essential vaccines for routine immunization programs. This would align with the African Union’s broader goal of increasing the continent’s vaccine manufacturing capacity to 60 percent by 2040, a target set in response to the disparities exposed by global health crises.
The Path Forward: Partnerships and Sustainability
The path to achieving this goal requires a tripartite collaboration between the government, the private sector, and international development partners. NAFDAC’s role is to provide the regulatory framework and oversight to ensure that any vaccine produced within the country meets the highest international safety and efficacy standards. The private sector, represented by organizations like PMG-MAN, provides the manufacturing infrastructure and technical expertise. International partners are expected to provide the technology transfer, funding, and technical guidance necessary to bridge the final gap in the regulatory ecosystem.
Prof. Adeyeye’s assertion that "you cannot give what you don’t have" highlights the internal capacity building that has been the hallmark of her tenure. By focusing on staff competence, laboratory infrastructure, and policy enforcement, NAFDAC has laid the groundwork for what it hopes will be the final step toward full international recognition.
As the 8th Nigeria Pharma Manufacturers Expo concludes, the consensus among stakeholders is clear: the transition toward local pharmaceutical sovereignty is no longer a distant ambition but a necessary operational reality. The success of this initiative will depend on the sustained political will of the Nigerian government to maintain favorable policies and the willingness of the global health community to support a regulatory agency that has already proven its commitment to international excellence. With the groundwork laid, the establishment of a fill-and-finish vaccine facility would serve as the definitive marker of Nigeria’s arrival as a serious, self-sufficient player in the global pharmaceutical landscape.
