The National Agency for Food and Drug Administration and Control has reiterated its dedication to ensuring the quality, safety, and effectiveness of generic medicines in Nigeria through the enforcement of stringent bioequivalence studies.
Speaking at a press briefing on Thursday in Lagos, the Director General of NAFDAC, Professor Moji Adeyeye, said the agency’s latest initiative is aimed at boosting public confidence in generic medications, curbing the spread of substandard drugs, and guaranteeing that generics deliver therapeutic effects comparable to those of their branded equivalents.
Bioequivalence studies, she explained, are crucial scientific evaluations that establish the interchangeability of generic drugs with their innovator counterparts. These assessments ensure that generics produce similar clinical outcomes, thereby confirming their reliability in treating various health conditions.
“By mandating bioequivalence studies, NAFDAC is strengthening its regulatory framework to safeguard public health,” Prof. Adeyeye said. “This measure not only enhances trust in the pharmaceutical industry but also encourages rational prescribing practices.”
In a bid to align stakeholders and promote compliance, the agency has mapped out a strategic roadmap that includes the issuance of comprehensive regulations and guidelines to the pharmaceutical sector. According to Prof. Adeyeye, these documents are now publicly available on NAFDAC’s official website.
Among the key documents released is a “Note to Industry,” which outlines the specific requirements for Contract Research Organisations involved in bioequivalence studies. These guidelines aim to streamline expectations and standardise procedures for all parties engaged in drug research and development.
To ensure smooth and effective implementation of these studies, NAFDAC is also investing in capacity building across the board. The agency has commenced training programmes for its staff, healthcare practitioners, researchers, and representatives of CROs.
“These training sessions ensure a shared understanding and smooth implementation of bioequivalence studies in Nigeria,” Prof. Adeyeye noted.
She added that the regulatory agency remains firmly committed to upholding rigorous scientific standards and called on all stakeholders to actively support the initiative.
“We call on pharmaceutical companies and healthcare providers to prioritise the use of generics that have undergone rigorous regulatory scrutiny and are duly approved by NAFDAC,” she said.
Prof. Adeyeye emphasised that the media engagement formed part of a broader series of stakeholder outreach efforts designed to keep the public and industry players informed and involved in maintaining a robust pharmaceutical regulatory system in Nigeria.
