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NAFDAC: No Full Approval for Herbal Drugs Without Clinical Trials

The National Agency for Food and Drug Administration and Control (NAFDAC) has reaffirmed that no herbal medicine in Nigeria will receive full approval without proper clinical trials.

In a statement issued on Sunday, October 12, 2025, by its Resident Media Consultant, Sayo Akintola, the agency said it is collaborating with the Nigeria Natural Medicine Development Agency (NNMDA) to develop scientifically tested and globally acceptable herbal medicines.

The partnership aims to promote safe, effective remedies backed by clinical evidence rather than speculation.

NAFDAC’s Director General, Prof. Mojisola Adeyeye, said Nigeria’s herbal medicine practitioners possess the expertise to produce effective natural formulations that can meet international health standards. But she stressed that safety and efficacy must first be proven scientifically.

The DG explained that the agency operates two levels of approval for herbal medicines: a two-year listing after safety evaluation, and a full five-year registration only after successful clinical trials.

“If you have an herbal medicine that you cannot prove scientifically the extent to which it works without causing harm to the user by providing data on efficacy, then it cannot be fully registered by NAFDAC,” she said.

Clinical Trials, a Costly but Necessary Step

Adeyeye acknowledged that the high cost of conducting clinical trials has discouraged many herbal producers. However, she warned that no product will be fully registered without scientific proof of safety and effectiveness.

She said NAFDAC has listed thousands of herbal products over the years, but only a handful have completed the rigorous process of clinical trials. “The fact that it’s natural doesn’t mean that it’s all safe. That’s where NAFDAC regulation and control come in,” she added.

According to her, dosage accuracy and organ safety—especially for the liver and kidneys—must be clearly established before full approval.

NAFDAC had earlier launched the Herbal Medicine Products Committee just before the COVID-19 pandemic to enhance cooperation between researchers, practitioners and the Federal Ministry of Health. The agency is now seeking funding support to help traditional medicine producers meet global clinical standards.

It is also working with NNMDA to identify promising herbal formulations for testing, with hopes of eventually incorporating them into Nigeria’s first national herbal medicine formulary.

As Adeyeye put it, “We are educating practitioners on registration processes and good manufacturing practices because our goal is not just to promote herbal medicine, but to make sure it is safe, effective, and of good quality.”


What will it take for Nigeria’s traditional healers to bridge the gap between ancestral wisdom and modern science?
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