NAFDAC, NNMDA Collaborate to Validate Herbal Medicines Through Clinical Trials

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced a partnership with the Nigeria Natural Medicine Development Agency (NNMDA) to ensure local herbal medicines meet global scientific and regulatory standards. The collaboration aims to subject selected herbal products to clinical trials, establishing their safety, efficacy, and dosage levels.

Prof. Mojisola Adeyeye, Director-General of NAFDAC, disclosed this in a statement issued by the agency’s Resident Media Consultant, Sayo Akintola, on Sunday. She emphasized that Nigerian herbal practitioners have the knowledge and capacitn to produce effective indigenous remedies but must validate them scientifically to gain full regulatory approval.

“NAFDAC conducts two types of approval for herbal medicines. The first is ‘listing’ approval, granted after toxicology tests in our laboratories. Products in this category receive a two-year NAFDAC number ending with ‘L’. The second requires clinical trials to prove efficacy. Only then can a product earn full approval valid for five years,” Prof. Adeyeye explained.

She noted that high costs often prevent practitioners from pursuing clinical trials. “Without scientific evidence demonstrating safety and efficacy, full registration is impossible. Thousands of herbal medicines are listed with NAFDAC, but only a few have undergone clinical trials,” she said.

Prof. Adeyeye stressed the need to scientifically determine safe dosage levels. “Natural products are not automatically safe. Overdosing can damage vital organs like the liver and kidneys. NAFDAC’s regulation ensures patient safety,” she added.

The Director-General also highlighted NAFDAC’s efforts to educate herbal practitioners through stakeholder meetings and guides published on the agency’s website. She recalled the launch of the Herbal Medicine Products Committee before the COVID-19 pandemic, which brought together practitioners, researchers, and regulatory authorities to strengthen collaboration.

Prof. Adeyeye, who previously led research on anti-sickling polyherbal medicine in the United States, said NAFDAC intends to mobilize funding to support clinical trials and fully register herbal medicines that meet regulatory standards.

“We are determined to assist our practitioners in conducting clinical trials. Together with NNMDA, we will ensure that scientifically validated herbal products are included in a national formulary,” she concluded.