By Musa Adekunle
The National Agency for Food and Drug Administration and Control has announced that all generic medicines in Nigeria must now undergo bioequivalence (BE) studies before they can be approved.
The agency made this known during a press briefing in Lagos yesterday. According to the Director General of NAFDAC, Prof. Mojisola Adeyeye, the decision is part of a wider regulatory plan to ensure that generic drugs deliver the same results as branded medicines.
Adeyeye said: “Bioequivalence (BE) is a critical scientific concept that ensures the quality, safety, and efficacy of generic drug products compared to their innovator counterparts.
“By ensuring that generics meet these standards, NAFDAC, as the national regulatory authority, is fulfilling its mandate to safeguard public health through a robust, science-based regulatory framework.”
The DG explained that BE studies were key to avoiding treatment failures, reducing fake drugs in circulation, and building trust in Nigeria’s healthcare system.
“Implementing BE studies fosters confidence in the therapeutic equivalence of generic medicines, which are widely used in Nigeria. This initiative promotes public health by reducing the circulation of substandard medicines,” she added. She also revealed that NAFDAC had rolled out new regulations and guidelines for drug companies, all accessible on its official website.
According to her, the agency has issued comprehensive regulations and guidelines for the pharmaceutical industry, detailing how to achieve therapeutically equivalent generic drug products through BE studies.
She added that NAFDAC also introduced a “Note to Industry” and trained staff and industry players, including researchers, CROs and healthcare workers, to properly understand the requirements. She urged the public to support and use only approved generics.
