The National Agency for Food and Drug Administration and Control (NAFDAC) has reaffirmed its dedication to ensuring the quality, safety, and effectiveness of generic medicines in Nigeria through the enforcement of stringent bioequivalence studies.
Speaking on Thursday in Lagos, NAFDAC Director General, Moji Adeyeye, emphasized that the initiative is designed to build public confidence in generic drugs, eliminate substandard medications from circulation, and ensure that generics offer therapeutic outcomes comparable to their branded equivalents.
“By mandating bioequivalence studies, NAFDAC is strengthening its regulatory framework to safeguard public health,” Adeyeye said. “This measure not only enhances trust in the pharmaceutical industry but also promotes rational prescribing practices.”
Bioequivalence studies are critical scientific evaluations that establish whether a generic drug performs in the same manner as its innovator counterpart. These assessments confirm the interchangeability of generics and help ensure their clinical effectiveness in treating medical conditions.
To support industry compliance and stakeholder alignment, NAFDAC has developed a strategic roadmap that includes issuing detailed regulations and guidelines for pharmaceutical companies. The agency has also published a “Note to Industry,” outlining requirements for Contract Research Organisations (CROs), all of which are available on its official website.
Furthermore, NAFDAC is investing in capacity building by training its personnel and engaging with key players in the sector, including healthcare professionals, researchers, and CROs.
Adeyeye noted that Thursday’s press briefing is part of a broader effort to keep stakeholders informed and actively involved in the agency’s mission to uphold a strong and effective pharmaceutical regulatory system in Nigeria.
