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Clinical Trials: NAFDAC, NNMDA partner to prove safety, efficacy of herbal medicines

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By Chioma Obinna

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 that Nigeria’s herbal medicines are scientifically tested, safe, and effective through properly conducted clinical trials.

Director-General of NAFDAC, Prof. Mojisola Adeyeye, disclosed this in Lagos, describing the collaboration as a major step toward global recognition for Nigeria’s indigenous natural remedies. She said the agency was determined to move beyond merely listing herbal products to granting full registration for those proven to be safe and efficacious through scientific validation.

“We know that herbal medicine works, but it is important to ascertain, through clinical trials, the level at which it can be safely used,” Adeyeye explained. “Below a certain dose, it may heal; above that, it could damage the liver, kidney, or other organs. The fact that something is natural doesn’t mean it is entirely safe.”

Adeyeye noted that the cost of clinical trials remains a major barrier preventing many herbal practitioners from scientifically validating their products. “If you have an herbal medicine that you cannot prove scientifically, then it cannot be fully registered by NAFDAC,” she said.

She explained that NAFDAC currently operates a two-tier approval process for herbal medicines. The first level, known as “listing,” follows laboratory evaluation for toxicology and safety. Such products receive a temporary approval number with the letter “L” at the end, valid for two years. The second level involves full clinical trials to establish efficacy and safety, leading to a five-year approval and inclusion in the national formulary.

“We have listed thousands of herbal medicines in Nigeria, but only a few have gone through clinical trials and proven efficacy. We cannot give a five-year approval without that process,” Adeyeye said.

She recalled that, before the COVID-19 pandemic, NAFDAC launched the Herbal Medicine Products Committee, bringing together herbal practitioners, researchers, and the Ministry of Health. “This collaboration is vital because the practitioners know what their forefathers used, while the researchers understand the science behind it. By bringing both together, we can bridge the gap between tradition and evidence-based medicine,” she said.

Adeyeye revealed that NAFDAC and NNMDA are now selecting promising herbal medicines already listed by the agency for clinical trials. “We are working with NNMDA to use some selected herbal medicines to conduct clinical trials so that we can have data to back up their claims. Once proven, such medicines will be fully registered and included in the national formulary,” she explained.

She added that NAFDAC has intensified capacity-building for herbal practitioners through stakeholder meetings and facility guidance. 

“It doesn’t have to be a big factory, but it must be properly organised to prevent contamination and ensure good workflow,” she said.

Adeyeye stressed that the agency would continue to support local herbal manufacturers through training and regulatory guidance but warned that no product would receive full registration without scientific evidence of safety and efficacy.

“Our goal is to ensure that Nigerian herbal medicines are not just popular locally but trusted globally. That trust can only come through science,” she said.

The post Clinical Trials: NAFDAC, NNMDA partner to prove safety, efficacy of herbal medicines appeared first on Vanguard News.

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