{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T20:58:27Z","timestamp":1792184307205,"version":"4.4.0"},"reference-count":69,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,12,5]],"date-time":"2025-12-05T00:00:00Z","timestamp":1764892800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"\n Background<\/jats:title>\n Recognizing the widespread use of herbal medicines, regulating them to ensure their safe registration, quality, and efficacy is of vital importance. Various countries in Africa have developed guidelines for the registration and subsequent market authorization of herbal medicine products. In this article, we aim to examine the registration procedures of locally manufactured herbal medicine (LMHM) products in four selected African countries for comparative purposes.<\/jats:p>\n <\/jats:sec>\n \n Method<\/jats:title>\n Document analysis was used to evaluate and interpret official and legal documents identified from the official websites of the drug regulatory authorities (DRAs) in the selected countries [Ghana, Nigeria, Uganda, and Zimbabwe]. These countries are selected based on the study\u2019s objectives to examine the regulatory framework, guidelines, and legislation on the registration procedures and requirements of LMHMs.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n In Ghana, Nigeria, and Uganda, the registration process offers a simplified pathway for LMHMs before market authorization. In Nigeria, LHMHs are listed, whereas in both Ghana and Uganda, they are notified. In Zimbabwe, herbal products are registered as either complementary medicines for general sale or pharmacy complementary medicines. In Nigeria and Uganda, the herbal product will undergo 2 years of pharmacovigilance for post-market surveillance after approval. Products are recalled when complaints occur during pharmacovigilance. In Ghana, yearly and periodic renewals are being done for already registered products. In Uganda, after 2\u00a0years of product tracking, the herbal product is then fully registered with the National Drug Authority. The minimum requirements for registering herbal medicines are to ensure product safety, efficacy, and quality. In all selected countries, emphasis is placed on safety and quality. Additionally, experiences reported by physicians, traditional practitioners, or treated patients also serve as evidence for therapeutic efficacy. In all countries, herbal products must conform to existing labeling regulations.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n The registration of LMHMs is simplified in selected African countries. However, despite this flexibility, few LMHM products get registered and obtain market authorization. Drug regulatory authorities in Africa must address the challenges that hinder the registration of herbal products and take action to promote the local production of herbal medicines while complying with the fundamental registration criteria for product safety, efficiency, and quality control.<\/jats:p>\n <\/jats:sec>","DOI":"10.3389\/fphar.2025.1695809","type":"journal-article","created":{"date-parts":[[2025,12,5]],"date-time":"2025-12-05T06:27:06Z","timestamp":1764916026000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["Comparative study of the registration procedure of locally manufactured herbal products in selected African countries"],"prefix":"10.3389","volume":"16","author":[{"given":"Aisha","family":"Gambo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nceba","family":"Gqaleni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Limakatso","family":"Lebina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lehlohonolo J.","family":"Mathibe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,12,5]]},"reference":[{"key":"B1","article-title":"\u201cWhat is on the traditional herbal medicine label? Technical communication and patient safety in Ghana,\u201d","volume-title":"Tech. Comm","author":"Agboka","year":"2021"},{"key":"B2","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1007\/s40290-018-0223-0","article-title":"International comparison of five herbal medicine registration systems to inform regulation development: united Kingdom, Germany, United States of America, United Arab Emirates and Kingdom of Bahrain","volume":"32","author":"Alostad","year":"2018","journal-title":"Pharm. Med."},{"key":"B3","doi-asserted-by":"publisher","first-page":"1267398","DOI":"10.3389\/fphar.2023.1267398","article-title":"Ghana\u2019s herbal medicine industry: prospects, challenges and ways forward from a developing country perspective","volume":"14","author":"Asase","year":"2023","journal-title":"Front. Pharmacol."},{"key":"B4","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1089\/acm.2013.0125","article-title":"Clinical efficacy of a West African sorghum bicolor-based traditional herbal preparation jobelyn shows increased hemoglobin and CD4+ T-Lymphocyte counts in HIV-positive patients","volume":"20","author":"Ayuba","year":"2014","journal-title":"J. Altern. Complement. Med."},{"key":"B5","doi-asserted-by":"publisher","first-page":"202","DOI":"10.34172\/jhp.2021.22","article-title":"Safety monitoring of herbal medicines in Nigeria: worrying state of pharmacovigilance system based on WHO core pharmacovigilance indicators","volume":"10","author":"Balogun","year":"2021","journal-title":"J. Herbmed Pharmacol."},{"key":"B6","doi-asserted-by":"publisher","first-page":"27","DOI":"10.3316\/qrj0902027","article-title":"Document analysis as a qualitative research method","volume":"9","author":"Bowen","year":"2009","journal-title":"Qual. Res. J."},{"key":"B7","article-title":"Promoting herbal medicine in Uganda the cross-cultural foundation of Uganda","year":"2008"},{"key":"B8","doi-asserted-by":"publisher","first-page":"177","DOI":"10.3389\/fphar.2013.00177","article-title":"The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety","volume":"4","author":"Ekor","year":"2014","journal-title":"Front. Pharmacol."},{"key":"B9","volume-title":"Herbal medicinal products","year":"2025"},{"key":"B10","doi-asserted-by":"publisher","first-page":"132","DOI":"10.15406\/ppij.2024.12.00443","article-title":"A critical examination of labeling practices in herbal medicinal products","volume":"12","author":"Faria","year":"2024","journal-title":"Pharm. Pharmacol. Int. J."},{"key":"B11","unstructured":"Guideline for authorization of clinical trials of medicines, food supplements, vaccines and medical devices in Ghana. Available"},{"key":"B12","volume-title":"Guideline on labelling of drugs","author":"Authority","year":""},{"key":"B13","article-title":"The food and drugs authority (FDA)","year":"2025"},{"key":"B14","volume-title":"Traditional, complementary and alternative medicine","year":"2025"},{"key":"B15","first-page":"2581","article-title":"Post-market safety and efficacy surveillance of herbal medicinal products from users\u2019 perspective: a qualitative semi-structured interview study in Kumasi, Ghana","volume":"3","author":"Frank","year":"2019","journal-title":"Int. J. Pharm. Pharmacol."},{"key":"B16","doi-asserted-by":"publisher","first-page":"1304839","DOI":"10.1155\/2022\/1304839","article-title":"Safety and efficacy of medicinal plants used to manufacture herbal products with regulatory approval in Uganda: a cross-sectional study","volume":"2022","author":"Kaggwa","year":"2022","journal-title":"Evid. Based Complement. Altern. Med."},{"key":"B17","doi-asserted-by":"publisher","first-page":"e001517","DOI":"10.1136\/bmjgh-2019-001517","article-title":"Towards universal health coverage: advancing the development and use of traditional medicines in Africa","volume":"4","author":"Kasilo","year":"2019","journal-title":"BMJ Glob. Health"},{"key":"B18","doi-asserted-by":"publisher","first-page":"391","DOI":"10.1186\/s12906-024-04697-7","article-title":"Study design of herbal medicine clinical trials: a descriptive analysis of published studies investigating the effects of herbal medicinal products on human participants","volume":"24","author":"Koonrungsesomboon","year":"2024","journal-title":"BMC Complement. Med. Ther."},{"key":"B19","doi-asserted-by":"crossref","DOI":"10.5703\/1288284317428","article-title":"Compliance to GMP guidelines for herbal manufacturers in East Africa: a position paper","volume-title":"BIRS Africa technical report papers","author":"Kwesiga","year":"2021"},{"key":"B20","article-title":"Guideline on submission of documentation for registration of complementary medicines medicines control authority of Zimbabwe","year":""},{"key":"B21","article-title":"Medicines and allied substances control (complementary medicines) regulations, 2015","year":"","journal-title":"Statutory Instrum. 97 2015. WE_RE_FD_97_20150911 PDF (swm-programme.info) Zimbabwe"},{"key":"B22","article-title":"Guidelines for clinical trial application and authorization in Zimbabwe","year":"2024","journal-title":"MCAZ-PVCT-GL-04-Rev-2_August-2024-Guidelines-for-Clinical-Trial-Application-and-Authorization-in-Zimbabwe PDF"},{"key":"B23","article-title":"Preparation, standardization, and quality control of medicinal plants in Africa","volume-title":"Medicinal spices and vegetables from Africa","author":"Mikhail","year":"2017"},{"key":"B24","article-title":"Policy guidelines on traditional medicine development","volume-title":"Traditional-medicine-policy pdf","author":"Health","year":"2005"},{"key":"B25","volume-title":"Public health act 851","year":"2012"},{"key":"B26","volume-title":"The republic of Uganda","year":"2025"},{"key":"B27","volume-title":"Traditional medicine","year":"2023"},{"key":"B28","doi-asserted-by":"publisher","first-page":"248","DOI":"10.1016\/j.bjp.2014.03.006","article-title":"Traditional use and safety of herbal medicines","volume":"24","author":"Moreira","year":"2014","journal-title":"Rev. Bras. Farmacogn."},{"key":"B29","article-title":"Month-end deadline for traditional medical practitioners registration","author":"Moyo","year":"2019","journal-title":"Chronicle"},{"key":"B30","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1186\/s12906-025-04812-2","article-title":"Traditional medicine regulation status and challenges in Malawi and Nigeria","volume":"25","author":"Mponda","year":"2025","journal-title":"BMC Complement. Med. Ther."},{"key":"B31","volume-title":"Celebrating \u2018herb 25\u2019","author":"Muhammad","year":"2011"},{"key":"B32","unstructured":"Approval For Listing Status By NAFDAC"},{"key":"B33","article-title":"Guidance to applicants for registration of herbal medicines made in nigeria","volume-title":"National agency for food and drug administration and control (NAFDAC)","author":"Directorate","year":""},{"key":"B34","unstructured":"Clinical trial regulations"},{"key":"B35","volume-title":"Guidelines for production inspection of herbal medicines and nutraceuticals manufacturing facilities","year":""},{"key":"B36","article-title":"Guidelines for registration of herbal medicines and dietary supplements made in Nigeria national agency for food and drug administration and control (NAFDAC), drug registration and regulatory affairs (DR&R) directorate","year":""},{"key":"B37","article-title":"Herbal medicine and related products registration regulations 2021","volume-title":"Federal Republic of Nigeria official gazette","author":"Control","year":""},{"key":"B38","unstructured":"Clinical trial\n \n \n 2024"},{"key":"B39","unstructured":"National agency for food and drug administration and control (NAFDAC)\n \n \n 2025"},{"key":"B40","volume-title":"Drug analysis for herbalists and general public","year":"2024"},{"key":"B41","unstructured":"Natural chemotherapeutics research institute (Uganda: NCRI)\n \n \n 2025"},{"key":"B42","article-title":"Guidance on herbal medicines","year":"2017","journal-title":"Uganda National Drug Authority (NDA)"},{"key":"B43","article-title":"Guidelines clinical research on herbal medicines","year":"2020","journal-title":"Guidelines-clinical-research-on-herbal-medicines PDF"},{"key":"B44","article-title":"Guidelines for regulation of local traditional\/herbal medicines for human or veterinary use in Uganda","year":"2021"},{"key":"B45","article-title":"Guidelines on good manufacturing practice for medicinal products1 part 1 \u2013 basic requirements for medicinal products doc. No ins\/gdl\/001-(part 1), revision no. 5","year":"2024","journal-title":"INS-GDL-001_Part-1_GMP-Guidelines-for-Medicinal-Products_R5 PDF"},{"key":"B46","unstructured":"National drug authority\n \n \n \n 2025"},{"key":"B47","doi-asserted-by":"publisher","first-page":"59","DOI":"10.4314\/ajtcam.v9i1.9","article-title":"Recommendations for the development of regulatory guidelines for registration of traditional medicines in South Africa","volume":"9","author":"Ngcobo","year":"2012","journal-title":"Afr. J. Tradit. Complement. Altern. Med."},{"key":"B48","doi-asserted-by":"publisher","first-page":"5988","DOI":"10.3390\/ijerph18115988","article-title":"African herbal medicines: adverse effects and cytotoxic potentials with different therapeutic applications","volume":"18","author":"Okaiyeto","year":"2021","journal-title":"Int. J. Environ. Res. Public Health"},{"key":"B49","unstructured":"Herbal medicines in African traditional medicine\n \n \n \n Ozioma\n E.-O. J.\n \n \n Chinwe\n O. A. N.\n \n \n \n 2019"},{"key":"B50","doi-asserted-by":"publisher","first-page":"329","DOI":"10.4103\/0975-7406.168035","article-title":"Challenges and guidelines for clinical trial of herbal drugs","volume":"7","author":"Parveen","year":"2015","journal-title":"J. Pharm. Bioallied Sci."},{"key":"B51","first-page":"57","article-title":"Role of traditional medicine in primary health care: an overview of perspectives and challenges","volume":"14","author":"Payyappallimana","year":"2010","journal-title":"Yokohama J. Soc. Sci."},{"key":"B52","doi-asserted-by":"publisher","first-page":"295","DOI":"10.1007\/s00228-012-1353-z","article-title":"Contamination and adulteration of herbal medicinal products (HMPs): an overview of systematic reviews","volume":"69","author":"Posadzki","year":"2012","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"B53","unstructured":"Complimentary medicines guidelines\n \n \n 2024"},{"key":"B54","doi-asserted-by":"publisher","first-page":"500","DOI":"10.1007\/s12291-017-0678-x","article-title":"Lead poisoning due to herbal medications","volume":"32","author":"Sakharkar","year":"2017","journal-title":"Ind. J. Clin. Biochem."},{"key":"B55","doi-asserted-by":"publisher","DOI":"10.11604\/pamj-oh.2024.15.8.45309","article-title":"Regulation and practice of clinical trials of herbal medicines in French-speaking West African countries (WAEMU): current status and challenges","volume":"15","author":"Sangho","year":"","journal-title":"PAMJ-One Health"},{"key":"B56","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1177\/27536130241296823","article-title":"Contribution of ethnomedical use data to the marketing authorization of traditional herbal medicines in Mali","volume":"13","author":"Sangho","year":"","journal-title":"Glob. Adv. Integr. Med. Health"},{"key":"B57","unstructured":"Traditional and alternative medicine directorate (TAMD)\n \n \n 2025"},{"key":"B58","doi-asserted-by":"publisher","DOI":"10.5703\/1288284317434","article-title":"Herbal medicines registration process for Zimbabwe overview of the process","author":"Usai","year":"2021","journal-title":"BIRS Afr. Tech. Rep."},{"key":"B59","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1016\/j.sajb.2020.06.031","article-title":"Health, safety and quality concerns of plant-based traditional medicines and herbal remedies","volume":"133","author":"VAN Wyka","year":"2020","journal-title":"S Afr. J. Bot."},{"key":"B60","article-title":"Why we can\u2019t have reliable evidence for herbal therapies","author":"Walters","year":"2014","journal-title":"Conversat."},{"key":"B61","doi-asserted-by":"publisher","first-page":"16647","DOI":"10.1038\/s41598-022-21065-y","article-title":"Medically important bacteria isolated from commercial herbal medicines in Kampala city indicate the need to enhance safety frameworks","volume":"12","author":"Walusansa","year":"2022","journal-title":"Sci. Rep."},{"key":"B62","doi-asserted-by":"publisher","first-page":"1265178","DOI":"10.3389\/fphar.2023.1265178","article-title":"Advancing herbal medicine: enhancing product quality and safety through robust quality control practices","volume":"14","author":"Wang","year":"2023","journal-title":"Front. Pharmacol."},{"key":"B63","article-title":"Operational guidance: information needed to support clinical trials of herbal products","year":"2005","journal-title":"UNICEF\/UNDP\/World Bank\/World Health Organ. Special Programme Res. Train. Trop. Dis."},{"key":"B64","unstructured":"Guidelines for registration of traditional medicines in the WHO African region\n \n \n 2010"},{"key":"B65","unstructured":"Clinical trials\n \n \n 2022"},{"key":"B66","unstructured":"WHO global centre for traditional medicine\n \n \n 2022"},{"key":"B67","unstructured":"Traditional, complementary and integrative medicine\n \n \n 2024"},{"key":"B68","article-title":"Document analysis vs content analysis: a comparison","author":"Williams","year":"2025","journal-title":"Insight7"},{"key":"B69","unstructured":"Regions of Africa\n \n \n 2025"}],"container-title":["Frontiers in Pharmacology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2025.1695809\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,5]],"date-time":"2025-12-05T06:27:11Z","timestamp":1764916031000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fphar.2025.1695809\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,5]]},"references-count":69,"alternative-id":["10.3389\/fphar.2025.1695809"],"URL":"https:\/\/doi.org\/10.3389\/fphar.2025.1695809","relation":{},"ISSN":["1663-9812"],"issn-type":[{"value":"1663-9812","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,5]]},"article-number":"1695809"}}