NAFDAC updates benchmarks for pharmaceutical safety in Nigeria.

The National Agency for Food and Drug Administration and Control (NAFDAC) has reaffirmed its dedication to ensuring the quality, safety, and effectiveness of generic medications in Nigeria through the implementation of rigorous bioequivalence studies.

During a statement made on Thursday in Lagos, NAFDAC's Director General, Prof. Moji Adeyeye, emphasized that this initiative is designed to enhance public trust in generic drugs, aiming to eliminate the distribution of substandard products and to confirm that generics offer therapeutic effects comparable to those of their branded equivalents.

Bioequivalence studies are essential scientific evaluations that establish the interchangeability of generic medications with their original counterparts.

These assessments ensure that generic drugs provide similar clinical results, thereby confirming their efficacy in treating health conditions.

Prof. Adeyeye remarked, “By requiring bioequivalence studies, NAFDAC is fortifying its regulatory framework to protect public health.

“This initiative not only builds confidence in the pharmaceutical sector but also promotes responsible prescribing practices.”

To align stakeholders and ensure compliance, NAFDAC has developed a strategic roadmap that includes the issuance of detailed regulations and guidelines for the pharmaceutical industry.

The agency has also published a “Note to Industry” outlining the requirements for Contract Research Organizations, both of which can be accessed on NAFDAC’s official website.

Furthermore, she highlighted that NAFDAC is investing in capacity building by providing training for its personnel and key industry stakeholders, including healthcare professionals, researchers, and CROs.

“These training sessions are designed to foster a common understanding and facilitate the effective implementation of bioequivalence studies in Nigeria.

“The regulatory agency has reiterated its commitment to maintaining high scientific standards and has called upon all stakeholders to support this 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,” said Adeyeye.

She maintained that the press briefing was part of a broader series of engagements designed to keep stakeholders informed and involved in the agency’s efforts to maintain a robust pharmaceutical regulatory system in Nigeria.