NAFDAC, NNMDA move to fast-track herbal drug clinical trials
The National Agency for Food and Drug Administration and Control (NAFDAC) has announced a major collaboration with the Nigeria Natural Medicine Development Agency (NNMDA) to speed up the clinical trial process and registration approval of herbal medicines in the country.
This was contained in a statement on Sunday signed by Prof Mojisola Adeyeye, Director-General of NAFDAC, who disclosed that the partnership aims to produce scientifically proven, safe, and effective herbal medicines that meet global standards.
The statement reads partly: “Nigerian herbal medicine practitioners have the capacity to formulate safe and effective indigenous natural remedies that meet international standards. NAFDAC has two types of approval for herbal medicines.
“The first type is a listing (L) approval, and it is granted after the product has been evaluated in our laboratory for toxicology safety tests with satisfactory results. Products in this approval category are listed for a period of two years, with a NAFDAC number bearing the letter L at the end. The second approval type requires that clinical trials be conducted on the product to prove the efficacy of such a product. If this is done (in a well-designed protocol) with proven efficacy, a full approval with five-year validity is given.
“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 some data on the efficacy, then it cannot be fully registered by NAFDAC.
“We know that herbal medicine works. It is how to ascertain through clinical trial the level it can be used below which patients will be safe, and above which there could be damage to the liver, the kidney, and other internal organs,” she explained, stressing that “the fact that it’s natural doesn’t mean that it’s all safe. That’s where NAFDAC regulation and control come in.”
“We are determined to assist our practitioners in the area of clinical trials, and together with NNMDA, we shall mobilise resources to get some herbal medicines fully registered after going through due process.”
Prof Adeyeye identified high costs as a major barrier preventing herbal medicine practitioners from subjecting their products to clinical trials. She noted that NAFDAC had listed thousands of herbal medicines, but only a few have successfully undergone clinical testing.
According to her, NAFDAC cannot grant full five-year approval for any herbal product that has not passed the efficacy test through a clinical trial. She said the collaboration with NNMDA would focus on identifying listed herbal medicines that have met regulatory requirements for further testing.
Prof Adeyeye recalled that the Agency established the Herbal Medicine Products Committee before the COVID-19 pandemic, bringing together practitioners, researchers, NAFDAC, and the Ministry of Health. She said the synergy was vital since practitioners possessed traditional knowledge while researchers brought scientific expertise.
She explained that the Agency was working closely with the NNMDA to conduct clinical trials for selected listed herbal medicines. “Once these are proven to be effective,” she said, “they can be placed in a national formulary for herbal medicines.”
The NAFDAC boss revealed that the Agency had been sensitising herbal medicine producers through stakeholder meetings and published guidelines. She noted that factory size was less important than maintaining a well-ordered, contamination-free production process.
Prof Adeyeye also shared her personal experience in herbal medicine development, revealing that before her appointment as Director-General of NAFDAC, she served as a professor in the United States, where she led a project that produced an anti-sickling polyherbal medicine.
She said the medicine, previously listed by NAFDAC, had been tested in laboratory settings using blood samples from children with sickle cell disease, and two research papers had confirmed its anti-sickling and anti-infective properties.
She further disclosed that she conducted a clinical trial on the medicine, approved by the Ethics Committee of Bowen University and the Institutional Review Board of her U.S. university, showing efficacy though more funding was required to complete the study.
The NAFDAC DG said the Agency is seeking funding to support herbal practitioners in conducting full-scale clinical trials, which are capital-intensive.
She reaffirmed NAFDAC’s commitment to working with the NNMDA and other stakeholders to ensure that only herbal medicines proven to be safe and effective are fully registered and included in the national formulary.