The National Agency for Food and Drug Administration and Control (NAFDAC) has announced partnership with the Nigeria Natural Medicine Development Agency (NNMDA) to foster and aid the registration and licensing of scientifically proven herbal medicines.
Herbal medicines have been in existence for ages. Inability to prove the consumption and side effects, its dosage has greatly impacted the growth of herbal medicines in the 21st Century.
The Director General of NAFDAC, Prof. Mojisola Adeyeye, via press release has reassured that Nigerian herbal medicine practitioners have the capacity to formulate safe and effective indigenous natural remedies that meet international standards.
She also stated that: NAFDAC has two types of approval for herbal medicines. The first type is a ‘listing’ (L) approval, and it is granted after the
The National Agency for Food and Drug Administration and Control (NAFDAC) has announced partnership with the Nigeria Natural Medicine Development Agency (NNMDA) to foster and aid the registration and licensing of scientifically proven herbal medicines.
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.
She explained that while thousands of herbal products have been listed, very few have undergone clinical trials due to the high cost involved. “If you have an herbal medicine that you cannot prove scientifically to be effective and safe through clinical trials, it cannot be fully registered by NAFDAC,” she said. “We know that herbal medicine works, but we must determine the dosage range that ensures patient safety and prevents damage to internal organs like the liver and kidney.”
She emphasised that the collaboration with NNMDA will help to identify and fund selected listed herbal medicines for clinical trials, enabling those that pass to be fully registered and included in a proposed national formulary for herbal medicines. “We are working together with NNMDA to ensure that clinical trials are conducted for herbal medicines that have met all regulatory listing requirements. This will help us prove beyond doubt that the medicines work well and can be safely recommended,” she said.
To support compliance, NAFDAC has been organizing stakeholder sensitization meetings and publishing simplified production guidelines for herbal practitioners.
Adeyeye noted that while manufacturing spaces do not have to be large, they must adhere to proper hygiene and workflow standards to prevent contamination.
She also drew reference to her experience leading a team that developed an anti-sickling polyherbal medicine before her appointment as NAFDAC DG. The medicine, listed years earlier by NAFDAC, demonstrated both anti-sickling and anti-infective effects in laboratory and clinical trials conducted in collaboration with Bowen University and a U.S. institution.
“We are determined to assist our herbal medicine practitioners in conducting clinical trials,” she affirmed. “Together with NNMDA, we will mobilize resources to ensure that selected herbal medicines are scientifically validated and fully registered after going through the due regulatory process.”
Prof. Adeyeye reiterated that NAFDAC remains committed to improving public health through evidence-based regulation of natural medicine, ensuring that Nigeria’s rich herbal heritage gains international recognition for its safety, quality, and therapeutic value.
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