Bioequivalence (BE) is a critical scientific concept that ensures the quality, safety, and efficacy of generic drug products in comparison to their innovator counterparts. It establishes the interchangeability of generic medicines with their branded equivalents, relying on statistically significant clinical outcomes to confirm that generics deliver comparable therapeutic effects. Innovator drugs undergo rigorous phases of clinical trials and scientific evaluation, and generic drug products are expected to provide similar clinical outcomes when used in healthcare settings. To confirm that generics are therapeutically equivalent and interchangeable—capable of treating or managing conditions as effectively as innovator medicines, hence bioavailability and bioequivalence (BA/BE) studies are essential.
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, averting therapeutic failures, boosting trust in the pharmaceutical industry and healthcare system, and encouraging rational prescribing practices. 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 that mandates BA/BE studies for all medicinal products in Nigeria.
To achieve this, NAFDAC has developed a strategic roadmap and is implementing it systematically to align stakeholders and facilitate compliance.
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. These documents are accessible on NAFDAC’s official website (www.nafdac.gov.ng).
Second, a specific “Note to Industry” has been released, outlining requirements for Contract Research Organizations (CROs), also available on the website. Third, NAFDAC is investing in capacity building by training its staff and stakeholders—including healthcare practitioners, researchers, CROs, and industry players. This ongoing training ensures a shared understanding and supports a smooth, effective, and sustainable implementation process.
This press briefing is part of a series of engagements designed to keep stakeholders informed and involved. NAFDAC reaffirms its unwavering commitment to upholding the quality, safety, and efficacy of generic medicines in Nigeria by mandating BE study. The Agency calls on all stakeholders and the public to support this initiative by prioritizing the use of generic products that have undergone rigorous regulatory scrutiny and are duly approved by NAFDAC.
Thank you.
Prof Mojisola Christianah Adeyeye FAS
Director General
