Vaccine Manufacturing Gap Delays NAFDAC’s WHO Level 4 Certification

The director-general of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, said absence of local vaccine manufacturing capacity is delaying the attainment of World Health Organisation (WHO) Maturity Level 4 certification for vaccine lot release by the agency.

Adeyeye in a statement by the media consultant, Sayo Akintola, disclosed this at the 8th Nigeria Pharma Manufacturers’ Expo in Lagos, where she called on international development partners and organisations in the healthcare sector to support the establishment of vaccine manufacturing facilities in Nigeria.

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She said Nigeria had made significant progress in strengthening its medicines and vaccines regulatory system and had been benchmarked in eight of the nine functions and requirements necessary to attain the relevant WHO regulatory maturity standards.

According to her, the outstanding requirement is vaccine lot release, which cannot be fully achieved without local vaccine manufacturing capacity.

The NAFDAC boss therefore urged international partners that had supported the agency’s regulatory development to extend their intervention to the establishment of fill-and-finish modular vaccine manufacturing facilities in Nigeria.

“We want to call on our international partners that have been of tremendous help. Without them we wouldn’t have been here. I want to challenge them to contribute, to fill and finish Modular Vaccine manufacturing so that we can get our Vaccine Lot Release,” she said.

Adeyeye said Nigeria already had most of the requirements needed to attain WHO Maturity Level 4 for vaccine lot release, stressing that the remaining gap was local vaccine production.

“To get Lot Release -Maturity Level 4, we have figured it out in a way we have estimated. It’s not going to cost too much. We will share that with you. Because we cannot afford to go back to where we used to be,” she said.

She recalled that Nigeria previously had the capacity to manufacture vaccines, saying the country must now rebuild that capability as part of efforts to strengthen medicine security and reduce dependence on imports.

She said, “It’s high time we went back to vaccine manufacturing.”

The NAFDAC DG also commended President Bola Ahmed Tinubu for the 2024 Executive Order on local pharmaceutical manufacturing, which she said had provided critical incentives to manufacturers operating under difficult economic conditions.

“I understand the stress our manufacturers are going through. Our manufacturers are patriots because they could have given up. I was championing incentives for the manufacturers until President Tinubu came on board with the Executive Order of 2024,” she said.

According to her, the executive order helped bring greater attention to the pharmaceutical and regulatory ecosystem and provided impetus for efforts to unlock value across the industry’s value chain.

She said, “nobody heard of us outside the regulatory and manufacturing industry and the gain that we have attained from regulatory and industry were not brought to the surface until the President came up with the Executive Order.”

Adeyeye added that the Coordinating Minister of Health and Social Welfare and the Minister of State for Health at the time also supported the push for incentives, which contributed to the initiative to unlock the pharmaceutical value chain.

She said the transformation of Nigeria’s pharmaceutical regulatory environment had been a gradual process, beginning with efforts to strengthen Good Manufacturing Practice (GMP) compliance among local manufacturers.

According to her, NAFDAC inspectors carried out routine GMP inspections of more than 165 companies over an eight-month period, with support from the United States Agency for International Development (USAID) and execution by the United States Pharmacopeia.

“We started the journey of not just the industry making products but making quality products because this is intricately tied to the way the patient’s positive health outcomes during treatment. There would not be treatment failure,” she said.

Adeyeye said the improvement in manufacturing standards had also translated into a significant reduction in the importation of products under the ‘5 plus 5’ and Ceiling Initiative between 2021 and 2025.

She said data from NAFDAC’s matrix showed that imports under the initiatives had declined by 70 per cent during the period, as local manufacturers increasingly responded to the challenge of producing quality medicines locally.

“We went into our data matrix, and we realised that we had decreased import of products under ‘5 plus 5’ and the Ceiling Initiative by 70 per cent because our manufacturers took up the challenge and came up with ‘yes we can,’” she said.

The NAFDAC DG said local manufacturers were increasingly demonstrating their commitment to improving the quality of medicines available to Nigerians while positioning themselves to compete in the international market.

She attributed the progress to continued investment in the competence of NAFDAC personnel, stressing that effective regulation depended on the capacity of regulators themselves.

“You cannot give what you don’t have,” she said.

Adeyeye said the reforms had also attracted international recognition for NAFDAC, noting that the agency became a member of the International Medical Device Regulators Forum in 2023, while its laboratory in Yaba became WHO pre-qualified in September 2023.

She explained that WHO Maturity Level 3 was not a one-time certification, as the global health body periodically returns to assess whether a regulatory authority has maintained the required standards.

According to her, NAFDAC became the first regulatory agency in sub-Saharan Africa to successfully undergo re-benchmarking after attaining Maturity Level 3.

“All this is because of our industry. It’s because of our citizens,” she said, stressing that NAFDAC, like other regulatory agencies across the world, is assessed against international standards regardless of the size or economic status of the country.

Meanwhile, the Chairman of the Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMG-MAN), Mr Oluwatosin Jolayemi, said the expo remained a major platform for pharmaceutical manufacturers, regulators, investors, development partners and other stakeholders to build partnerships and strengthen the industry.

Jolayemi, who is also the Managing Director/Chief Executive Officer of Daily Need Limited, commended Adeyeye for her efforts towards moving Nigeria’s pharmaceutical manufacturing industry in line with international best practices in quality and GMP compliance.

He said the impact of NAFDAC’s regulatory policies was becoming increasingly visible across the pharmaceutical ecosystem, but stressed the need to sustain the gains.

Jolayemi also called for the extension of the presidential Executive Order on pharmaceutical manufacturing for another two years when it expires in March 2027.

He said the extension was necessary because the drive towards medicine security and pharmaceutical sovereignty could not be achieved through short-term interventions.

According to him, the sector requires policy consistency, sustained investment, capability development and a predictable operating environment to achieve long-term growth.

A total of 132 companies from the United States, China, Argentina, Egypt, India, Rwanda, Austria, the United Arab Emirates, France, Germany, Indonesia and Nigeria, among others, participated in the two-day expo.