By Doris Obinna
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 on Thursday, in Lagos, the Director General, NAFDAC, Prof Mojisola Adeyeye, emphasized 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 Organizations (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.
“NAFDAC urged all parties involved in the pharmaceutical sector to embrace the regulatory requirements and prioritize the use of generics that have passed rigorous scientific and regulatory evaluation.
“With the full enforcement of BE studies for all medicinal products, NAFDAC is taking significant strides in protecting public health, fostering industry accountability, and ensuring that only therapeutically effective and scientifically approved generics are available to Nigerian consumers,” she added.
Adeyeye further disclosed that Nigeria is aligning itself with international best practices in bioequivalence by adopting a phased approach. According to the Director-General, newly submitted pharmaceutical products are now required to come with bioequivalence data.
“While the implementation is still in its early stages, the agency is focusing first on essential medicines, including anti-malarials, antibiotics, and drugs for maternal and child health.”
The process, she noted, will take time to fully integrate across all medicines in circulation. The agency has also taken steps to engage with foreign manufacturers, especially those in India, where a significant number of Nigeria’s medicines are sourced.
“Virtual meetings have been held with Indian manufacturers to emphasize the need for compliance with bioequivalence requirements before exporting products to Nigeria.
“Also, manufacturers within the country have reportedly started responding positively to these new requirements. NAFDAC is also taking steps to ensure that only certified institutions are authorized to conduct bioequivalence studies and that all submitted data is properly validated and trustworthy.”