By Ekaete Ekong
The National Agency for Food and Drugs Administration and Control NAFDAC has called on stakeholders and members of the public to support the campaign of prioritising the use of generic products that have undergone regulatory scrutiny and are duly approved by NAFDAC.
Implementing Bioequivalence (BE), studies fosters confidence in the therapeutic equivalence of generic medicines, which are widely used in Nigeria.
The Director -General, NAFDAC, Professor Mojisola Adeyeye who made the call at a news briefing in Lagos noted that, all medicinal products in Nigeria”.
Bioequivalence (BE) which she described as a critical scientific concept that ensures the quality, safety, and efficacy of generic drug products in comparison to their innovator counterparts,
It establishes the fact that generic medicines are interchangeable with their branded equivalents, relying on statistically significant clinical outcomes to confirm that generics deliver comparable therapeutic effects.
According to the DG, 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.” She stressed
Professor Mojisola pointed out that, implementing BE studies fosters confidence in the therapeutic equivalence of generic medicines, which are widely used in Nigeria.
The initiative she explained, 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, 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.
To this end, 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). encouraging everyone to get squinted with.
Another step is that, a specific “Note to Industry” has been released, outlining requirements for Contract Research Organizations (CROs), also available on the website.
While the last step is that, ” NAFDAC is training it’s staff and stakeholders—including healthcare practitioners, researchers and industry players.
Professor Mojisola noted that, the ongoing training ensures a shared understanding and supports a smooth, effective, and sustainable implementation process.
The briefing is to show further NAFDAC unwavering commitment to upholding the quality, safety, and efficacy of generic medicines in Nigeria by mandating BE study.
