By Jemimah Wellington, JKNewsMedia Correspondent
THE NATIONAL Agency for Food and Drug Administration and Control (NAFDAC) has called on pharmaceutical manufacturers to make decisive investments that will enable the local production of human vaccines in Nigeria.
Director General of the Agency, Prof. Mojisola Adeyeye, issued the call while warning that the nation must not wait for another pandemic before preparing adequately, noting that Nigeria’s heavy dependence on international donors during the COVID-19 crisis exposed the need for local vaccine manufacturing capacity.
According to Prof. Adeyeye, the Agency has already strengthened its regulatory system for vaccines, biologics, and medical devices through a comprehensive restructuring and global benchmarking process.
She explained that the restructuring was designed to enhance transparency, accountability, and efficiency in NAFDAC’s regulatory framework.
“When I came to NAFDAC, we had the Registration and Regulatory Affairs Directorate, which was in charge of registration of all NAFDAC-regulated products such as food, drugs, cosmetics, medical devices, herbal medicines, vaccines, veterinary products, pesticides, and other finished chemicals, under one Director.
This made the system susceptible to ineffectiveness and corruption,” she said.
Prof. Adeyeye stated that she created a separate Food Registration and Regulatory Affairs Directorate and later carved out vaccines and medical devices from the Drug Registration and Regulatory Affairs Directorate to align with international best practices.
“One Director overseeing seven regulated products will not achieve the necessary efficiency. That was why we had to separate vaccines and medical devices,” she explained.
She revealed that in November 2024, NAFDAC established a dedicated Directorate for Vaccines, Biologics, and Medical Devices, following an assessment and approval by the Head of Service of the Federation.
This, she said, was part of the Agency’s preparations to meet World Health Organization (WHO) benchmarking requirements for vaccine regulation.
“For NAFDAC to be benchmarked for vaccines, biologics, and medical devices, we had to have a separate Directorate headed by a director to ensure alignment with international standards,” she said, noting that NAFDAC attained WHO Maturity Level 3 (ML3) for medicines and imported vaccines in 2022.
The Director General expressed optimism that Nigeria would begin manufacturing vaccines before the end of her tenure. “It will be exciting news for me because during the pandemic we were too dependent on foreign countries.
“We must decide as a country that we will not be too dependent on others. We will manufacture our own,” she said.
Prof. Adeyeye stressed that to achieve WHO prequalification, any country must have a regulatory system with at least ML3 status.
She added that while NAFDAC had achieved ML3 for seven of the eight modules under the WHO Global Benchmarking Tool, local vaccine manufacturing would enable the Agency to complete the process.
She also noted that NAFDAC remains the only National Regulatory Agency in sub-Saharan Africa with an in-house laboratory for vaccines, biologics, and medical devices.
“The South African Health Products Regulatory Authority (SAHPRA) has a laboratory for vaccines but contracted it out to private operators,” she said.
She explained that WHO officials had verified NAFDAC’s readiness for local vaccine oversight during a recent visit.
“We have almost satisfied every requirement except that the country must manufacture vaccines. It is when we start local production that we can conduct facility inspections,” she added.
Speaking on the regulatory readiness, Mrs. Khadijah Ade-Abolade, Director of Vaccines, Biologics, and Medical Devices Registration and Regulatory Affairs, said the Federal Government had already established policies and provided support to enable local vaccine production.
“All the required regulatory functions for the regulation of vaccines are already available. We are just waiting for manufacturing operations to begin,” she said.
Prof. Adeyeye concluded that Nigeria has the scientific and technical capacity to begin vaccine production through “Fill and Finish” processes while planning for full-scale manufacturing.
“We have sound scientists, and we have the support of President Bola Ahmed Tinubu, GCFR, who is encouraging local manufacturing under the Renewed Hope Agenda. Now is the time to get it done,” she stated.
