The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has called on international development partners to support Nigeria in establishing local vaccine manufacturing facilities. This appeal was made at the 8th Nigeria Pharma Manufacturers Expo in Lagos, jointly organised by the Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG-MAN) and PGE Expo PVT Limited. Adeyeye emphasized that the absence of local vaccine manufacturing capacity is delaying Nigeria's attainment of World Health Organisation (WHO) Maturity Level 4 for vaccine lot release.
Adeyeye highlighted that international partners have played a significant role in helping NAFDAC attain WHO Maturity Level 3 and urged them to extend their support to the establishment of fill-and-finish modular vaccine manufacturing facilities in Nigeria. According to her, NAFDAC has met eight of the nine functions and requirements needed to be fully benchmarked for the regulation of medicines and vaccines, with vaccine lot release remaining the final requirement. Adeyeye stressed that Nigeria has the regulatory capacity required to attain Maturity Level 4 but needs local vaccine manufacturing capacity to complete the process.
The NAFDAC boss recalled that Nigeria had previously manufactured vaccines and emphasized that the country must return to local vaccine production as part of efforts to strengthen medicine and health security. Adeyeye commended President Bola Ahmed Tinubu for the 2024 Executive Order on healthcare manufacturing, which she said provided much-needed incentives for local pharmaceutical manufacturers operating under difficult economic conditions. The government's intervention has contributed to efforts to unlock Nigeria's pharmaceutical value chain and strengthen local production.
Adeyeye noted that NAFDAC had earlier embarked on a Good Manufacturing Practice (GMP) Roadmap, during which inspectors conducted compliance audits of more than 165 companies across the country over eight months, with support from USAID and the United States Pharmacopeia. The initiative aimed not only to increase local production but also to ensure that medicines manufactured in Nigeria met international quality standards. As a result, NAFDAC's data showed a 70 per cent reduction between 2021 and 2025 in the importation of products affected by the 5+5 policy and Ceiling Initiative.
The reduction in importation was attributed to increased capacity among local manufacturers, who responded positively to the regulatory challenge by improving production capacity and quality standards. Adeyeye disclosed that NAFDAC's efforts to strengthen the competence of its personnel had also contributed to the agency's growing international recognition. In 2023, NAFDAC became a member of the International Medical Device Regulators Forum, while its laboratory in Yaba, Lagos, became WHO-prequalified in September of the same year.
Adeyeye noted that WHO Maturity Level 3 was not a one-off achievement, as the international body periodically reassesses regulatory agencies to determine whether they have maintained the required standards. NAFDAC became the first regulatory agency in sub-Saharan Africa to successfully undergo the re-benchmarking process the first time. The Chairman of PMG-MAN, Mr Oluwatosin Jolayemi, described the expo as a major platform for pharmaceutical manufacturing in Central and West Africa, bringing together manufacturers, regulators, investors, development partners, and other stakeholders.
The two-day expo attracted 132 participating companies from various countries, including the United States, China, Argentina, Egypt, India, Rwanda, Austria, the United Arab Emirates, France, Germany, Indonesia, and Nigeria. Jolayemi commended Adeyeye for her efforts to move Nigeria's pharmaceutical industry towards international best practices in quality and GMP compliance. He called for an extension of the Presidential Executive Order for another two years when it expires in March 2027, arguing that medicine security and pharmaceutical sovereignty could not be achieved through short-term interventions.
Key points
- NAFDAC seeks international support to establish local vaccine manufacturing facilities.
- Nigeria aims to attain WHO Maturity Level 4 for vaccine lot release.
- The country has made progress in strengthening its pharmaceutical industry, including a 70 per cent reduction in importation of certain products.
