The National Agency for Food and Drug Administration and Control (NAFDAC) says reforms implemented over the past seven years have strengthened Nigeria’s public health system, reduced deaths linked to fake and substandard medicines, and elevated the country’s profile among global drug regulators.
Speaking at a media briefing on Wednesday, the Director-General of NAFDAC, Prof. Mojisola Adeyeye, said the transformation, which began in 2018, was anchored on stronger leadership, improved legal frameworks, quality management systems and extensive digitalisation of regulatory processes.
She said a key outcome of the reforms was Nigeria’s attainment of the World Health Organization’s Global Benchmarking Tool Maturity Level 3 for medicines regulation in 2022, followed by a successful re-benchmarking in 2025, making NAFDAC the first regulatory authority in Africa to achieve the milestone twice. In the same year, the agency was admitted as the 24th member of the International Council for Harmonisation.
Adeyeye said the strengthened regulatory framework has significantly reduced the circulation of poor-quality medicines, particularly oxytocin, a life-saving drug used to prevent maternal deaths during childbirth. According to her, studies conducted before the reforms showed that about 70 per cent of oxytocin in circulation was substandard, a figure that dropped to about seven per cent by 2021 following intensified surveillance and enforcement.
She also disclosed that recent nationwide operations targeting open drug markets resulted in the seizure and destruction of over N1 trillion worth of falsified and substandard medicines, as the agency adopted a risk-based, intelligence-driven enforcement strategy.
Adeyeye said digital platforms deployed for product registration, clinical trial approvals, laboratory testing, port inspections and post-market surveillance have improved transparency, reduced turnaround times and strengthened product traceability. She added that a digital track-and-trace system deployed during the COVID-19 pandemic enabled the monitoring of vaccine distribution nationwide and the interception of compromised vaccine batches.
According to her, regulatory modernisation has also boosted local pharmaceutical and medical device manufacturing through policies such as the 5plus5 initiative and the Ceiling List, reducing dependence on imports and encouraging domestic production, foreign investment and technology transfer.
She added that NAFDAC has strengthened food safety and chemical regulation, including new rules on trans fats, pesticides, veterinary medicines and high-alcohol-content sachets, while positioning the agency to target WHO Maturity Level 4 status as it deepens digitalisation and regulatory reliance.
Adeyeye further said the reforms have increased Nigeria’s influence in global regulatory governance, enabling the country to share expertise, participate in international standard setting and attract partnerships in pharmaceuticals, medical devices, and chemical safety. She stressed that sustained investment in people, laboratories, infrastructure and technology remains critical to safeguarding public health.
She also highlighted NAFDAC’s commitment to public education, saying campaigns on drug safety, proper storage of medicines, and responsible consumption of food and alcohol products have been intensified, aiming to build awareness and prevent harm from substandard or falsified products.
On traditional and herbal medicines, she said NAFDAC already regulates and inspects herbal products through a two-stage approval process. “The agency is now collaborating with the Nigeria Natural Medicine Development Agency (NNMDA) to conduct clinical trials on selected herbal remedies, with the aim of developing a national formulary of scientifically validated herbal medicines,” she added.
Daily Sun