NAFDAC’s New Rule Could Change How Generic Drugs Are Made in Nigeria – Here’s Why It Matters”

In a major move to improve the quality of medicines in Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) has announced that all generic medicines must now undergo bioequivalence (BE) studies before they can be approved for use in the country.

This announcement was made on Thursday during a press briefing in Lagos by the Director-General of NAFDAC, Prof. Mojisola Adeyeye.

“Bioequivalence is a critical scientific concept that ensures the quality, safety, and efficacy of generic drug products in comparison to their innovator counterparts,” said Prof. Adeyeye.

What This Means

Simply put, BE studies confirm that a generic drug works the same way as the original branded version. This helps ensure that patients get the same therapeutic benefits from generics, which are often more affordable.

According to NAFDAC, the new requirement is part of a broader plan to:

• Reduce treatment failures,

• Combat the spread of fake and substandard drugs,

• And build public trust in Nigeria’s healthcare system.

New Regulations and Industry Training

NAFDAC has also rolled out new regulations and published detailed guidelines for pharmaceutical companies on its website. The agency is actively training:

• Drug manufacturers,

• Contract Research Organizations (CROs),

• Healthcare professionals,

• And researchers…

…to ensure a smooth transition and effective implementation of these new standards.

“This ongoing training ensures a shared understanding and supports a smooth, effective, and sustainable implementation process,” Adeyeye said.

A Call to Action

NAFDAC is urging the public to support and demand only approved generics, as this initiative marks a significant step toward a safer, more reliable pharmaceutical industry in Nigeria.

With the new policy, NAFDAC continues to reinforce its role as a science-based regulator dedicated to public health protection.