The National Agency for Food and Drug Administration and Control (NAFDAC) says it is partnering with the Nigeria Natural Medicine Development Agency (NNMDA) to conduct clinical trials on herbal medicines before granting full approval for their use.
Gatekeepers News reports that according to the agency, herbal medicines in Nigeria currently receive two categories of approval. The first, known as a listing (L) approval, is issued after laboratory evaluation and toxicology safety tests yield satisfactory results. Products under this category are assigned a NAFDAC number ending with the letter “L” and are valid for two years.
The second category requires clinical trials to scientifically establish a product’s efficacy. Successful products in this group receive full approval with a validity period of five years.
In a statement on Sunday, NAFDAC Director-General, Prof. Mojisola Adeyeye, said Nigerian herbal medicine practitioners have the capacity to formulate safe and effective indigenous remedies that can meet international standards.
However, she noted that the cost of conducting clinical trials remains a major challenge for most practitioners.
“If you have an herbal medicine that you cannot prove scientifically the extent to which it works without causing harm to the user by providing data on its efficacy, then it cannot be fully registered by NAFDAC,” Adeyeye said.
She revealed that thousands of herbal medicines have been listed by NAFDAC, but only a few have undergone clinical trials and demonstrated proven efficacy.
“We cannot give a five-year approval without passing the efficacy test through a clinical trial,” she explained.
“We know that herbal medicine works, but it is through clinical trials that we can determine safe dosage levels and avoid potential harm to vital organs such as the liver and kidney. The fact that it’s natural doesn’t mean it’s all safe.”
Adeyeye added that NAFDAC’s collaboration with the NNMDA aims to help practitioners who have met regulatory requirements progress from listing to full registration.
“We want to prove beyond doubt that these medicines work effectively so they can be fully registered and included in a national formulary for herbal medicines,” she said.
“We are working with practitioners and moving toward a phase where clinically tested herbal medicines will gain national and international recognition.”
