In a renewed effort to eliminate substandard drugs and enhance public trust in pharmaceutical products, the National Agency for Food and Drug Administration and Control (NAFDAC) has unveiled stringent regulatory reforms aimed at enforcing the quality and safety of generic medicines in Nigeria.
Speaking during a high-level stakeholders’ engagement in Lagos on Thursday, the Director General of NAFDAC, Professor Mojisola Adeyeye0, announced that the agency would now strictly enforce bioequivalence studies as a requirement for the approval of generic drugs.
The move, she said, is aimed at aligning with international best practices and ensuring that all medications circulating in Nigeria’s healthcare system are both safe and therapeutically effective.
Bioequivalence studies are scientific evaluations used to verify that a generic drug performs in the same way as its branded counterpart. These studies confirm that a generic product releases its active ingredient into the bloodstream at the same rate and in the same amount as the original drug.
“These studies are not just bureaucratic formalities,” said Prof. Adeyeye. “They are essential scientific procedures that protect patients and ensure they receive the full benefit of the medicine they are prescribed.”
Nigeria’s pharmaceutical market has long struggled with the influx of counterfeit and ineffective drugs, which has led to treatment failures, antibiotic resistance, and, in some cases, preventable deaths. The introduction of stricter bioequivalence mandates is therefore seen as a proactive step to eliminate substandard and falsified medicines from the Nigerian drug supply chain.
“With this policy, NAFDAC is reinforcing its commitment to health safety and regulatory transparency,” Prof. Adeyeye said.
Strategic Roadmap for Implementation
To support this transition, NAFDAC has rolled out a multi-faceted strategic plan that includes:
Updated regulations and guidelines for pharmaceutical manufacturers
A publicly available “Note to Industry” that outlines the requirements for Contract Research Organisations (CROs)
Enhanced compliance and enforcement protocols
Continuous training and capacity building for both regulators and industry players
NAFDAC’s official website now houses detailed documentation on the new bioequivalence standards and operational expectations for companies involved in drug development and distribution.
Prof. Adeyeye emphasized that the regulatory changes were not designed to punish pharmaceutical firms but to promote industry-wide compliance, innovation, and improved patient outcomes. The agency is actively collaborating with CROs, healthcare professionals, and academic researchers to ensure seamless adoption of the new rules.
“We are not just enforcing regulations—we are educating and supporting our stakeholders to make the transition smoother and more impactful,” she said.
As part of its capacity-building efforts, NAFDAC has conducted workshops and training sessions involving pharmacists, doctors, researchers, and CRO executives. These sessions aim to demystify the technical aspects of bioequivalence studies and reinforce the ethical responsibilities of all participants in the drug supply chain.
Supporting the Growth of Generic Medicines in Nigeria
While branded drugs remain expensive and often out of reach for the average Nigerian, generic medicines provide a cost-effective alternative. However, widespread skepticism has surrounded the effectiveness of these generics.
NAFDAC’s new policy is designed to restore consumer confidence in locally available generics by ensuring that they meet global safety and efficacy standards.
“Trust is everything in healthcare,” said Prof. Adeyeye. “By raising the regulatory bar, we are making Nigerian generics more competitive, not only locally but in international markets as well.”
NAFDAC has also called on healthcare providers to play a central role in implementing the policy. Doctors, pharmacists, and healthcare workers are being encouraged to prescribe and dispense only NAFDAC-approved generics that meet bioequivalence standards.
Healthcare institutions have been advised to update their procurement guidelines to align with the agency’s new requirements and avoid unverified pharmaceutical products that could compromise patient care.
This initiative is part of a broader reform by NAFDAC under Prof. Adeyeye’s leadership to make Nigeria’s healthcare system safer, more transparent, and more resilient. From tackling drug smuggling and counterfeit operations to improving lab testing capacity, the agency has taken significant strides in repositioning itself as a global-standard regulatory body.
“Our mission is not only to regulate but to protect lives,” Prof. Adeyeye concluded. “This is a national health priority, and we expect full support from the pharmaceutical industry, healthcare sector, and the general public.”