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NAFDAC, NNMDA Collaborate to Advance Clinical Trials for Safe, Herbal Medicines


The National Agency for Food and Drug Administration and Control (NAFDAC) has announced a strategic partnership with the Nigeria Natural Medicine Development Agency (NNMDA) to advance the development of herbal medicines, ensuring they meet rigorous safety, efficacy, and international standards. 


The collaboration aims to elevate Nigeria’s herbal medicine industry to global prominence, according to a statement by NAFDAC’s resident media consultant, Olusayo Akintola.


NAFDAC Director-General, Prof. Mojisola Adeyeye, emphasized the untapped potential of Nigerian herbal medicine practitioners. “Our practitioners have the knowledge to formulate safe and effective indigenous remedies that can compete on the world stage,” she said. 


However, she stressed that regulatory oversight is critical to ensure these products are both safe and effective, addressing a common misconception that “natural” automatically means safe.


Under NAFDAC’s regulatory framework, herbal medicines undergo one of two approval processes. 


The first, a “listing” (L) approval, follows laboratory toxicology and safety tests. Products meeting these standards receive a two-year listing with a NAFDAC number ending in ‘L’. 


The second, a full five-year approval, requires clinical trials to prove efficacy through a well-designed protocol. 


“Thousands of herbal medicines are listed, but only a handful have undergone clinical trials,” Adeyeye noted, citing high costs as a major barrier for practitioners.


"Clinical trials are essential to determine safe dosage levels and prevent harm to vital organs like the liver or kidneys,” she explained. 


“Herbal medicines work, but we need data to ensure patient safety and global acceptance.” 


To address this, NAFDAC is actively seeking funding to support practitioners in conducting these capital-intensive trials, in collaboration with the NNMDA.


The partnership builds on initiatives like the Herbal Medicine Products Committee, launched just before the COVID-19 pandemic, which unites practitioners, researchers, the Ministry of Health, and NAFDAC. 


“Practitioners bring ancestral knowledge, while researchers provide scientific rigor,” Adeyeye said. 


“Together, we can create a national formulary for clinically proven herbal medicines.”NAFDAC is also intensifying efforts to educate practitioners through stakeholder meetings and has published a simplified factory floor plan on its website to guide production. 


“You don’t need a massive facility,” Adeyeye clarified, “but it must be well-organized to ensure smooth workflows and prevent contamination.” 


The agency approves herbal medicines daily but is pushing for a future where more products achieve full approval through clinical trials.Reflecting on her own experience, Adeyeye shared that, as a professor in the U.S. before joining NAFDAC, she led a project developing an anti-sickling polyherbal medicine. 


“The trials showed promise, but we needed more data and funding,” she said, underscoring the challenges Nigerian practitioners face today.


As NAFDAC and NNMDA work to bridge these gaps, the partnership signals a transformative step for Nigeria’s herbal medicine sector. 


With increased funding and regulatory support, the agencies aim to empower practitioners to produce safe, effective remedies that gain trust both at home and abroad. 


For now, Adeyeye urges practitioners to leverage NAFDAC’s resources and comply with regulations to unlock the full potential of Nigeria’s rich herbal heritage. 

  

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