NAFDAC Tightens Drug Regulations to boost Confidence in Generic Medicines

In a move to reinforce public trust in Nigeria’s pharmaceutical industry, the National Agency for Food and Drug Administration and Control (NAFDAC) has introduced stricter regulatory measures that mandate bioequivalence studies for generic medicines.

Addressing journalists in Lagos on Thursday, NAFDAC Director General, Prof. Moji Adeyeye, said the new policy was designed to ensure that generic drugs are as effective and reliable as their branded counterparts.

“You cannot outsource the health of your people,” Adeyeye stressed, pointing out that bioequivalence studies are now non-negotiable in determining whether generic drugs can be safely substituted for original brands. “These studies guarantee that generic drugs deliver similar clinical outcomes, ensuring their effectiveness in managing health conditions.”

NAFDAC’s new regulations come at a time when public concern over substandard drugs is growing. Adeyeye explained that this step would prevent the infiltration of ineffective generics and promote rational prescribing.

“By mandating bioequivalence studies, NAFDAC is strengthening its regulatory framework to safeguard public health,” she said. “This measure not only enhances trust in the pharmaceutical industry but also encourages rational prescribing practices.”

To ensure smooth implementation, the agency has developed a comprehensive roadmap for pharmaceutical companies. This includes detailed guidelines and a “Note to Industry” specifying expectations for Contract Research Organisations (CROs). Both documents are accessible on NAFDAC’s official website.

NAFDAC is also investing in capacity building to bridge knowledge gaps among industry players. “These training sessions ensure a shared understanding and smooth implementation of bioequivalence studies in Nigeria,” Adeyeye noted, adding that stakeholders—ranging from healthcare practitioners to researchers and CROs—are being actively engaged.

As part of its broader mission, the agency is calling on stakeholders to embrace this new standard. “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.

Adeyeye affirmed that the media briefing was part of an ongoing dialogue with industry players, aimed at reinforcing NAFDAC’s role in protecting public health and building a robust pharmaceutical regulatory system in the country.