The National Agency for Food and Drug Administration and Control (NAFDAC), has reinforced its commitment to ensuring the quality, safety, and efficacy of generic medicines in Nigeria through the mandatory implementation of Bioequivalence (BE) studies.
This is contained in a statement signed by Prof. Mojisola Adeyeye, Director-General/CEO posted via agency’s official X Account that bioequivalence is a critical scientific concept that confirms the therapeutic interchangeability of generic drugs with their branded counterparts, ensuring that generics provide the same clinical benefits as innovator medicines.
To achieve this, the statement said “NAFDAC has established a strategic regulatory framework mandating Bioavailability and Bioequivalence (BA/BE) studies for all medicinal products in Nigeria.
The agency also said “it has published detailed regulations and guidelines on its official website, along with a “Note to Industry” specifying requirements for Contract Research Organisations (CROS). Additionally, NAFDAC is investing in capacity building by training stakeholders; including healthcare practitioners, researchers, and pharmaceutical industry players, to facilitate compliance and enhance public confidence in generic medicines.
“This press briefing marks another step in NAFDAC’s ongoing stakeholder engagement to promote awareness and compliance. The Agency urges all stakeholders to support this initiative by prioritising the use of NAFDAC-approved generics that meet stringent regulatory standards. Through this science-based approach, NAFDAC continues to safeguard public health and strengthen Nigeria’s pharmaceutical sector.”
