Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) said on Sunday that no herbal product will receive full regulatory approval without undergoing clinical trials to prove its safety and effectiveness.
The agency is working with the Nigeria Natural Medicine Development Agency (NNMDA) to develop herbal medicines that meet international standards through scientific validation.
NAFDAC Director-General Prof. Mojisola Adeyeye said while Nigerian practitioners have the expertise to formulate effective remedies, clinical trials remain essential for full approval.
“Natural products are not automatically safe. Safe dosage levels must be scientifically determined,” she said, noting that the high cost of trials discourages many from seeking full registration.
Currently, NAFDAC grants “listing approval” for two years after basic safety tests, while full registration requires clinical evidence of efficacy and is valid for five years.
Adeyeye said the agency continues to engage herbal practitioners and seeks funding to support costly trials, aiming to ensure locally made products are safe, effective, and internationally acceptable.