On Thursday, the National Agency for Food and Drug Administration and Control (NAFDAC) unveiled a new regulatory measure mandating bioequivalence, BE, studies for all generic drug products in Nigeria.
Disclosing this at a news briefing in Lagos, the agency noted that bioequivalence, as a critical scientific standard, will ensure that generic drugs deliver the same therapeutic benefits as their counterparts internationally.
Explaining in detail, the Director General of the Agency, Prof. Mojisola Adeyeye stated that the initiative is part of NAFDAC’s activities to protect public health, check the circulation of substandard medicines, and promote rational drug use.
“Bioequivalence is not just a scientific term—it is a commitment to quality, safety, and efficacy.
It assures the public that generic medicines will work just as well as the original brands they replace.
“Bioequivalence studies measure how a generic medicine is absorbed and distributed in the body compared to an innovator drug.
When properly conducted, these studies provide scientific proof that generics can be safely substituted in treatment.”
Recognizing the scale of the pharmaceutical market and the need for industry adjustment, she said NAFDAC is adopting a phased implementation approach.
She added that essential medicines such as antimalarial, antibiotics, and products for maternal and child health are being prioritized.
While acknowledging that only a small percentage of drugs currently meet the new standards, she disclosed that NAFDAC is receiving a growing number of submissions from local manufacturers responding to the mandate for BE study reports.
“We are not expecting 100 percent compliance overnight. But we are firm in our direction, and the industry is responding.
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She said 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).
“A specific “Note to Industry” has been released, outlining requirements for Contract Research Organisations (CROs), also available on the website.
“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.”
Adeyeye said the agency is also investing in capacity building, and training its regulatory staff, industry stakeholders, and healthcare practitioners to ensure broad understanding and seamless implementation of the new framework.
She revealed that it has held virtual meetings with key international manufacturers, mainly in India, to ensure that imported products also meet the new requirements.
“Any product coming into this country must meet our standards. If you're exporting to Nigeria, you must provide bioequivalence data.”
The agency also used the platform to caution the public against purchasing medicines from unlicensed sources such as kiosks and corner stores.
NAFDAC urged Nigerians to obtain medicines only from registered pharmacies where products are traceable.
“Do not buy drugs from unknown sources. When you buy from a certified pharmacy, we can trace the product through the receipt, and hold suppliers accountable if problems arise.”
She further cited a previous case where a faulty medicine was traced to a manufacturer in the Northwest zone, leading to the temporary closure of the production line until corrective actions were taken.
Nothing that the NAFDAC’s bioequivalence initiative was part of a broader effort to build a trusted, evidence-based pharmaceutical ecosystem in Nigeria, she reaffirmed the agency’s commitment to a transparent, science-led regulatory process that prioritizes the health and safety of all Nigerians.
“We are setting a new benchmark. Our goal is simple: to ensure that every medicine on the Nigerian market is effective, safe, and trusted. Bioequivalence is how we get there.”
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