{"id":122947,"date":"2025-10-12T20:13:22","date_gmt":"2025-10-12T19:13:22","guid":{"rendered":"https:\/\/pointblanknews.com\/pbn\/?p=122947"},"modified":"2025-10-12T20:13:22","modified_gmt":"2025-10-12T19:13:22","slug":"nafdac-nnmda-partner-to-standardise-approve-herbal-medicine","status":"publish","type":"post","link":"https:\/\/pointblanknews.com\/pbn\/news\/nafdac-nnmda-partner-to-standardise-approve-herbal-medicine\/","title":{"rendered":"\u200eNAFDAC, NNMDA Partner to Standardise, Approve Herbal Medicine"},"content":{"rendered":"
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By Daniel Adaji<\/div>\n
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\u200eThe National Agency for Food and Drug Administration and Control (NAFDAC) has entered into a partnership with the Nigeria Natural Medicine Development Agency (NNMDA) to strengthen the standardisation and scientific validation of herbal medicines through clinical trials.<\/div>\n
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\u200eAnnouncing the collaboration in a statement on Sunday, NAFDAC Director General, Prof. Mojisola Adeyeye, said the move is designed to simplify the approval process for herbal medicines while encouraging practitioners to subject their formulations to rigorous scientific testing.<\/div>\n
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\u200e\u201cNigerian herbal medicine practitioners have the capacity to formulate safe and effective indigenous natural remedies that meet international standards,\u201d she said.<\/div>\n
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\u200eThe initiative, according to her, aims to ensure that locally formulated herbal remedies are safe, effective, and meet international standards.<\/div>\n
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\u200eAdeyeye noted that NAFDAC grants two types of approvals for herbal medicines – Listing Approval and Full Registration Approval. Listing (L) Approval is issued after a product passes toxicology and safety evaluations in the agency\u2019s laboratories. Products under this category carry a NAFDAC number ending with the letter \u201cL\u201d and are valid for two years.<\/div>\n
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\u200eFull Approval, on the other hand, is granted only after clinical trials confirm the product\u2019s efficacy. This category carries a five-year validity and certifies that the medicine has undergone scientifically proven testing and demonstrated therapeutic benefits.<\/div>\n
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\u200eHowever, Adeyeye noted that the high cost of clinical trials remains a major obstacle for most traditional medicine practitioners.<\/div>\n
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\u200e\u201cIf 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,\u201d she said.<\/div>\n
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\u200eShe revealed that while thousands of herbal medicines have been listed, only a few have completed clinical trials.<\/div>\n
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\u200e\u201cWe cannot give five-year approval without passing the efficacy test through a clinical trial. 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,\u201d she stated.<\/div>\n
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\u200eAdeyeye emphasised that \u201cthe fact that it\u2019s natural doesn\u2019t mean that it\u2019s all safe. That\u2019s where NAFDAC regulation and control come in.\u201d<\/div>\n
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\u200eShe recalled that the agency established the Herbal Medicine Products Committee shortly before the COVID-19 pandemic to bring together practitioners, researchers, and the Ministry of Health to advance the development of indigenous remedies.<\/div>\n
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\u200e\u201cThis collaborative effort is very important because the practitioners know what their forefathers have been using, while the researchers know the science,\u201d she noted.<\/div>\n
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\u200eAccording to her, NAFDAC and NNMDA are now working closely to identify and fund the clinical testing of selected herbal medicines that have already met preliminary regulatory requirements.<\/div>\n
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\u200e\u201cWe are working together with the NNMDA to use some selected listed herbal medicines to conduct clinical trials, so that we will prove beyond doubt that the medicine works well and those can now be registered fully,\u201d she explained. \u201cSuch medicines can be placed in a national formulary for herbal medicines, even if there are few.\u201d<\/div>\n
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\u200eShe added that the agency continues to educate herbal medicine practitioners through stakeholder meetings and online resources. NAFDAC has also published a simple factory floor plan on its website to guide small-scale producers on good manufacturing practices.<\/div>\n
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\u200e\u201cIt does not necessarily have to be a big place to use for production,\u201d Adeyeye said, \u201cbut the factory must be well-ordered to allow a good workflow so that there will not be contamination.\u201d<\/div>\n
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\u200eShe further revealed that NAFDAC approves herbal medicines daily but is working towards developing a national formulary for products that have successfully passed clinical trials.<\/div>\n
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\u200eAdeyeye also shared her personal experience in herbal drug research. Before her appointment as NAFDAC DG, she served as a professor in the United States, where she led a project that developed an anti-sickling polyherbal medicine.<\/div>\n
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\u200eThe medicine, previously listed by NAFDAC, was tested in laboratories using blood samples from children with sickle cell disease and showed both anti-sickling and anti-infective properties.<\/div>\n
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\u200e \u201cWe conducted a clinical trial approved by the Ethics Committee of Bowen University and the Institutional Review Board of my University in the U.S on the polyherbal in July before my assumption of office in NAFDAC in November 2017,\u201d she stated.<\/div>\n
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\u200eAlthough the trial showed promising results, Adeyeye said more data and funding were needed to complete the study.<\/div>\n
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\u200e\u201cWe 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,\u201d she stated.<\/div>\n<\/div>\n<\/div>\n