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Tag: Prof. Mojisola Adeyeye

  • Why Nigeria hasn’t prequalified as vaccine-making status, by NAFDAC DG

    Why Nigeria hasn’t prequalified as vaccine-making status, by NAFDAC DG

    The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has explained why Nigeria has not attained the World Health Organisation (WHO) prequalification for locally manufactured vaccines.

    She said this is not due to a weak regulation but because the country has not begun actual production.

    Adeyeye said NAFDAC had met almost all WHO requirements but could not be fully benchmarked until local vaccine manufacturing begins.

    WHO prequalification serves as an international seal of quality, validating a country’s manufacturing standards and ensuring global acceptance of its vaccines.

    “WHO has confirmed that we have satisfied almost all indicators for vaccine lot release. The only remaining condition is that the country must manufacture vaccines locally, because only then can WHO assess our capacity for local facility inspection,” Adeyeye said in a statement by NAFDAC’s Resident Media Consultant, Sayo Akintola.

    For Nigeria, achieving this milestone would mark a major step towards self-reliance, economic resilience, and stronger epidemic preparedness.

    The NAFDAC director general urged local pharmaceutical manufacturers to invest in human vaccine production.

    Warning that Nigeria must not wait for another pandemic to build capacity, she said: “During COVID-19, we realised how dependent we were on foreign countries.

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    “We couldn’t get vaccines unless they were donated or imported. That was when it became clear that epidemic preparedness starts with local capacity.”

    Adeyeye stressed that although Nigeria has been producing veterinary vaccines since 1924, it still depends entirely on imports for human vaccines.

    “We must decide as a country that we will not continue to depend on others. We have the scientific capability; what we need is investment and commitment,” she added.

    According to her, Nigeria achieved Maturity Level 3 (ML3) status in 2022 for medicines and imported vaccines — a WHO benchmark that signifies a strong and functional regulatory system capable of ensuring product safety and quality.

    But Adeyeye explained that to qualify for vaccine prequalification, the country must also demonstrate the ability to regulate its manufacturing facilities.

    “When I assumed office, all regulated products — drugs, vaccines, medical devices, cosmetics, and pesticides — were under one directorate.

    “That system was inefficient and vulnerable to corruption. One director overseeing seven regulated areas cannot deliver efficiency,” she said.

    To address the anomaly, Adeyeye said NAFDAC underwent major restructuring, creating specialised units to improve governance and performance.

    “We separated vaccines and medical devices from the Drug Registration Directorate to form a dedicated Vaccines, Biologics, and Medical Devices Directorate,” she explained.

    The new directorate, approved by the Head of Service of the Federation and established in November 2024, the DG stated, positioned NAFDAC to operate at par with global standards.

    Adeyeye added that NAFDAC remains the only national regulatory agency in sub-Saharan Africa with an in-house laboratory for vaccines, biologics, and medical devices.

    “In South Africa, the Health Products Regulatory Authority outsources vaccine testing to private laboratories. Here, we do ours internally.

    “NAFDAC has been conducting lot release testing for imported vaccines for years. The WHO wants to see that we can do the same for locally manufactured ones — and that will happen once production begins,” she said.

  • Pharmaceutical drug import drops to 60% — NAFDAC DG

    Pharmaceutical drug import drops to 60% — NAFDAC DG

    The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has disclosed that pharmaceutical drug importation into Nigeria has dropped to 60 percent, as part of the agency’s ongoing reforms to promote local production and ensure national self-reliance in the pharmaceutical sector.

    Prof. Adeyeye made the revelation while speaking at the 2025 Investiture Ceremony and Lecture of Fellows of the Nigerian Academy of Pharmacy (NAPHARM) held  at the Old Great Hall, College of Medicine, LUTH, Lagos. The event tagged: Pharmaceutical Innovation as a Catalysts for National Development, featured Annual General Meeting, and Valedictory Session for Pharm, Chief Oludolapo Akinkugbe.

     Adeyeye, who delivered an impassioned address on nation building, urged Nigerians to take personal responsibility in transforming the country. She revealed that the importation of pharmaceuticals has dropped from 70% to about 60%, due to the agency’s efforts to encourage local manufacturing and strengthen regulatory capacity.

    “We said no, if we can make it in Nigeria, we will not continue importing after five years. Before now, only nine products were under import restriction; today, we have increased that number to 36 — because we can. Because we are building our nation,” she stated.

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    She said “Our manufacturers are patriots. They make their own life. They make their own water. I challenge our manufacturers. When we are talking of innovation, we have to start from the bottom because we work. I challenge them. How come we cannot make anything except water? That everything is imported. Now we have Emzo trying to finish an active pharmaceutical ingredient plant”.

    She also noted that Nigeria now has pre-qualified medical devices and two WHO-prequalified medicines for the first time in history, adding that the country is beginning to export pharmaceutical products across West and East Africa under the African Continental Free Trade Agreement (AfCFTA) framework.

    “Before my time, Nigeria had no WHO pre-qualified medical device. Now we have Afrimedical. We also have two pre-qualified medicines. God has not created us differently; He has given us capacity. We just need to use our pain productively,” she said.

    The NAFDAC boss recounted her experience upon assuming office in November 2017, describing the agency she met as “disillusioned and without focus.” She said the agency had to undergo a total mindset overhaul — what she described as “washing of the brain” — to reorient staff on the importance of excellence, documentation, and standard operating procedures.

    “Nation building starts from wherever we find ourselves. When I came into NAFDAC, the agency had almost nothing except disillusioned staff. We were at a regulatory ranking of minus one. But we made a decision — to compare ourselves not with ourselves, but with the best in the world,” she said.

    On innovation and technology, Adeyeye disclosed that NAFDAC has implemented a Track and Trace system to monitor vaccines and narcotics — making Nigeria the first national regulatory agency in Africa and the second in the world to achieve such a feat.

    She emphasized that linking academia, industry, and regulatory agencies is crucial to research and development, announcing that NAFDAC now supports staff to pursue postgraduate degrees while working full-time, through partnerships with universities such as the University of Lagos and Federal University of Technology, Minna.

    In his keynote address, The Group Managing Director of FBN Holdings Plc, Mr. Wale Oyedeji, called for a national commitment to research, technology adoption, and inter-sectoral collaboration to transform Nigeria’s healthcare and pharmaceutical landscape.

    Speaking on the theme of innovation and the future of pharmaceuticals, Mr. Oyedepo highlighted the critical role of science, research, and technology in building a healthier and more productive nation.

    “When we talk about biopharmaceuticals and artificial intelligence today, we must remember that in the 1960s, these were not even in our imagination,” he said. “Now, we must embrace them to change the trajectory of healthcare in Nigeria.

    Oyedeji commended countries like India and Rwanda for their strategic investments in research and technology, noting that Nigeria must not be left behind.

    “India, with over a billion people, is now a global leader in generic drug production. Rwanda, despite its past challenges, now uses drones to deliver medicines to remote areas. These are examples Nigeria must learn from,” he noted.

    He decried Nigeria’s heavy dependence on imported drugs—estimated at over 70 percent of total consumption—and called for increased investment in local research and development (R&D).

    Earlier in his welcome address, The President and Chairman, Governing Council of the Nigeria Academy of Pharmacy (NAPHARM), Professor Lere Baale, has reaffirmed the Academy’s commitment to advancing innovation, ethics, and excellence in pharmaceutical science as a catalyst for national development.

    In a message titled “Advancing the Essence, Relevance, and Future of Pharmacy,” described the event as “a day of symbolism and innovation,” coinciding with the 102nd anniversary of The Walt Disney Company — a global testament to the power of vision, creativity, and disciplined innovation.

    “It is profoundly symbolic that our 2025 Investiture holds on October 16, the day Walt and Roy Disney founded what became one of the world’s greatest innovation-driven enterprises,” Baale said. “Just as Disney transformed imagination into a global legacy through storytelling, science, and technology, our Academy is transforming pharmaceutical science into national impact — translating knowledge into innovation, and innovation into wellbeing.”

    He noted that the Nigeria Academy of Pharmacy stands as the custodian of pharmaceutical excellence, serving as the intellectual, professional, and moral compass of the pharmacy profession in Nigeria.

    The Academy, he said, represents “a fellowship of distinguished minds whose collective wisdom shapes science, influences policy, promotes innovation, and safeguards the integrity of healthcare delivery.”

    He added that The Nigeria Academy of Pharmacy is more than an institution — it is a living legacy, a community of leaders transforming pharmacy into a catalyst for innovation and national renewal. Together, let us advance the essence, relevance, and future of pharmacy for our people’s health, our nation’s strength, and the legacy of generations to come.”