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NAFDAC, NNMDA join forces to fast-track herbal drug approval

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By Doris Obinna

The National Agency for Food and Drug Administration and Control (NAFDAC) is collaborating with the Nigeria Natural Medicine Development Agency (NNMDA) to promote the development of safe, effective, and scientifically validated herbal medicines through clinical trials.

NAFDAC, in a statement signed by the Director General, Prof. Mojisola Adeyeye, disclosed that Nigerian herbal practitioners have the capacity to produce quality indigenous remedies that can meet international standards.

She explained that NAFDAC grants two types of approvals for herbal medicines: a two-year listing approval, indicated by an “L” on the NAFDAC number, after laboratory safety evaluation, and a full five-year approval granted only after successful clinical trials proving efficacy.

Adeyeye identified the high cost of clinical trials as a major obstacle facing herbal practitioners, noting that thousands of herbal products have been listed, but only a few have undergone efficacy testing.

“We know herbal medicine works, but we must scientifically determine safe and effective dosage levels,” she said, stressing that being natural does not automatically mean a product is safe.

She revealed that NAFDAC is working with NNMDA to conduct clinical trials on selected listed herbal medicines that meet regulatory requirements, with plans to include proven products in a national formulary for herbal medicines.

Adeyeye added that the agency continues to educate practitioners through stakeholder meetings and guidelines to ensure proper production standards. She also recalled leading a successful clinical trial on an anti-sickling polyherbal medicine before her appointment as NAFDAC DG, emphasising that the agency is now seeking funding to support similar research.

“We are determined to help our practitioners carry out clinical trials and get their products fully registered after due process,” she affirmed.



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