The National Agency for Food and Drug Administration and Control has announced a strategic partnership with the Nigeria Natural Medicine Development Agency in a significant move to advance the development of safe, effective, and scientifically validated herbal medicines in Nigeria.
This collaboration is aimed at ensuring that indigenous herbal products meet international safety and efficacy standards through the implementation of well-structured clinical trials.
In a statement issued on Sunday by NAFDAC’s media consultant, Sayo Akintola, the agency’s Director-General, Prof. Mojisola Adeyeye, affirmed that while Nigerian herbal medicine practitioners possess the expertise to produce world-class natural remedies, they must embrace scientific validation to gain global acceptance.
She emphasized the critical role of scientific testing in establishing safe dosage levels for these products.
“We know that herbal medicine works, but we must determine scientifically the safe dosage levels. Below a certain level, patients will be safe, but above it, there could be damage to vital organs such as the liver and kidneys,” Adeyeye stated.
She further clarified the agency’s oversight role, adding, “The fact that a product is natural doesn’t mean it’s completely safe—that’s where NAFDAC regulation and control come in.”
Prof. Adeyeye noted that the initiative seeks to bridge the gap between traditional knowledge and modern science, referencing a World Health Organisation statistic that about 80 per cent of Africans rely on herbal remedies for their primary healthcare needs.
She explained that NAFDAC provides two distinct categories of approvals for herbal products to guide practitioners through the validation process.
“The first type is a listing (L) approval, granted after toxicological safety tests have been conducted with satisfactory results. These products are listed for two years and bear NAFDAC numbers ending with ‘L’. The second category requires clinical trials to prove efficacy. Once the product passes such trials, it receives full registration, valid for five years,” she added.
However, the NAFDAC boss identified the high cost of clinical trials as a major challenge that discourages many herbal medicine producers from pursuing full validation and registration.
“If you have a herbal medicine but cannot scientifically prove its efficacy and safety, NAFDAC cannot grant it full registration,” she warned.
Prof. Adeyeye revealed that although thousands of herbal products have been listed by the agency, only a few have undergone the rigorous process of full clinical evaluation with verifiable outcomes.
She recalled that NAFDAC had established the Herbal Medicine Products Committee shortly before the COVID-19 pandemic to foster collaboration among researchers, practitioners, and government agencies.
“We are working to identify selected herbal medicines that have met regulatory requirements for clinical trials. Once proven effective and safe, they can be fully registered and included in the national formulary for herbal medicines,” she disclosed.
To address the financial barrier, Prof. Adeyeye said NAFDAC is actively seeking funding support to help traditional medicine practitioners carry out the necessary clinical trials. She stressed that while such research is capital-intensive, it is essential for the global acceptance of Nigerian herbal products.
The agency, she added, has continued to engage practitioners through regular stakeholder meetings to educate them on registration standards and best practices for ensuring product safety and efficacy.
The new partnership with NNMDA, she concluded, is expected to accelerate the process of transforming Nigeria’s rich traditional medicine heritage into a portfolio of globally recognized, scientifically validated healthcare solutions.
