The National Agency for Food and Drug Administration and Control (NAFDAC) 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 on Thursday.

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.

“Bioequivalence (BE) is a critical scientific concept that ensures the quality, safety, and efficacy of generic drug products in comparison to their innovator counterparts,” Adeyeye said.

“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 are 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 also revealed that NAFDAC has rolled out new regulations and guidelines for drug companies, all accessible on its official website.

“First, the Agency has issued comprehensive regulations and guidelines for the pharmaceutical industry, detailing how to achieve therapeutically equivalent generic drug products through BE studies.

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NAFDAC also introduced a “Note to Industry” and is training staff and industry players, including researchers, CROs, and healthcare workers, to ensure proper understanding of the requirements.

“This ongoing training ensures a shared understanding and supports a smooth, effective, and sustainable implementation process.”

The agency said this is one in a series of engagements aimed at involving more stakeholders in the fight for safe and effective medicine use in Nigeria.

It urged the public to support and use only approved generics.