By Chigbu Nwaobia
The National Agency for Food and Drug Administration and Control (NAFDAC) has introduced the Pharmaceutical Products (Traceability) Regulations, 2024, a landmark policy aimed at curbing counterfeit drugs and ensuring the quality of pharmaceutical products in the country.
This was disclosed during a two-day awareness workshop on the NAFDAC Greenbook, Pharmaceutical Products Traceability Regulations 2024, and Paediatric Regulation 2024, in Abuja recently.
Speaking at the workshop, the Director General of NAFDAC, Mojisola Adeyeye, said the menace of substandard and falsified medical products remains one of the gravest threats to human life and dignity in the country.
Prof. Adeyeye, who was represented by Gbenga Fajemirokun, Special Assistant to the DG, noted that despite sustained enforcement and public education efforts, counterfeiters have continued to devise more sophisticated methods, prompting NAFDAC to leverage modern technologies and innovative strategies to safeguard public health.
This initiative is crucial, considering the significant threat posed by substandard and falsified medical products to public health.
The new regulations mandate that manufacturers and supply chain stakeholders share data with NAFDAC for traceability, including details of production, distribution, and sales.
Key provisions include mandatory labelling with unique identifiers, such as Global Trade Item Number (GTIN), batch number, expiry date, and serial number, as well as machine-readable barcodes.
Traceability ensures that medicines are genuine, safe, and effective, protecting patients from counterfeit drugs. The policy also aligns Nigeria with global standards, enhancing the country’s pharmaceutical industry reputation, and enables real-time tracking, improving inventory management, reducing waste, and preventing theft.
Countries like the US, EU, and China have implemented similar regulations, yielding positive results. For instance, the US’s Drug Supply Chain Security Act (DSCSA) has improved drug safety and reduced counterfeiting.
NAFDAC has also launched the Greenbook app, an online database that allows consumers to verify the authenticity of medical products. The agency has urged marketing authorization holders to submit their products for visibility on the app.
The implementation of these regulations is expected to boost public trust in the healthcare system and improve health outcomes. As Prof. Mojisola Adeyeye, NAFDAC’s Director-General, noted, “Traceability is not merely a regulatory obligation, but a public health necessity”.
The new policy on pharmaceutical traceability is a significant step forward in Nigeria’s efforts to ensure the safety and efficacy of medical products. Led by Prof. Moji Adeyeye, NAFDAC has been working towards achieving Maturity Level 4, the highest rating given by the World Health Organization (WHO) for regulatory systems.
In recent times, NAFDAC has been actively implementing measures to combat counterfeit and substandard drugs. The agency has introduced the GreenBook, a digital verification platform, and the Pharmaceutical Products (Traceability) Regulation 2024, which mandates unique identifiers on pharmaceutical products. These efforts aim to enhance supply chain visibility and strengthen pharmacovigilance.
The latest policy direction is part of NAFDAC’s five-year traceability implementation plan, aligning with the Nigeria National Traceability Strategy Policy and the Africa Strategy for Pharmaceutical Traceability. This initiative is expected to improve patient safety, promote trust in the pharmaceutical sector, and support local manufacturing.
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