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By Vincent Kalu
The National Agency for Food and Drug Administration and Control (NAFDAC), has reaffirmed its commitment to ensuring the safety, efficacy, and quality of generic medicines in Nigeria through the implementation of a robust regulatory framework centered on bioequivalence (BE) studies.
At a press briefing in Lagos, the Director General, NAFDAC, Prof. Mojisola Adeyeye, emphasised that BE is a scientific principle crucial for establishing the therapeutic equivalence of generic drugs compared to their branded counterparts.
“By demonstrating that generics deliver similar clinical outcomes to innovator drugs, BE studies confirm that these medications are interchangeable and effective for treating health conditions. “Generic medicines play a significant role in Nigeria’s healthcare system due to their affordability and accessibility. NAFDAC’s regulatory initiative is aimed at eliminating substandard and ineffective medicines from the market, thereby enhancing public trust in the pharmaceutical industry and promoting rational prescribing practices.
“To ensure compliance, the Agency has developed and is actively implementing a strategic roadmap. As part of this plan, NAFDAC has issued comprehensive guidelines for pharmaceutical manufacturers, detailing the procedures and requirements for conducting BE studies. These guidelines are publicly available on the agency’s official website.”
According to her, a “Note to Industry” has been released, specifically addressing the operational expectations for Contract Research Organisations (CROs), which are also key players in the conduct of BE studies.
“To further bolster the success of the initiative, NAFDAC is investing in capacity building through continuous training for its personnel and key stakeholders, including healthcare providers, researchers, and industry participants.
“This press briefing forms part of a broader engagement strategy to keep stakeholders informed and aligned with the agency’s objectives,” she said.
