Sangho Aboubacar, Ouoba Kampadilemba, Semdé Rasmané, Sanogo Rokia
Teaching and Research Department of Pharmaceutical Sciences, Faculty of Pharmacy, University of Sciences, Techniques and Technology of Bamako (USTTB), Bamako, Mali.
Drug Development Laboratory, African Center of Excellence for Training, Research, and Expertise in Pharmaceutical Sciences (CEA-CFOREM), Sciences and Health Doctoral School, Training and Research Unit in Health Sciences, Joseph KI-ZERBO University, Ouagadougou, Burkina Faso.
Glob Adv Integr Med Health. 2024 Oct 24;13:27536130241296823. doi: 10.1177/27536130241296823. eCollection 2024 Jan-Dec.
To improve the supply of health care and health care products, traditional herbal medicines that are safe, effective, and of good quality need marketing authorizations. This study aims to determine the contribution of ethnomedical evidence to the marketing of traditional herbal medicines in Mali.
This was a descriptive cross-sectional study conducted from December 2023 to March 2024 supplemented by a literature review of the legislative and regulatory provisions relating to traditional medicine and the requirements for marketing authorization of traditional herbal medicines in Mali and the West African sub-region.
The regulatory framework for marketing authorization is governed by decree no. 04-557/P-RM of 01 December 2004 and interministerial order no. 05-2203/MS-MEP-SG of 20 September 2005 in Mali. These texts set out the specific requirements for the marketing authorization of traditional plant-based medicines, depending on the category. They consider ethnomedical evidence drawn from long experience of traditional use as proof of efficacy and tolerance for category 2 traditional medicines. As a result, marketing authorizations were issued for 15 products derived from traditional medicine and pharmacopeia, 5 of which are included in the National List of Essential Medicines and the National Therapeutic Formulary of Mali.
The use of ethnomedical evidence provides a good opportunity to obtain marketing authorization for phytomedicines derived from traditional medicine without having to go through long and costly non-clinical and clinical studies.
为改善医疗保健和保健产品的供应，安全、有效且质量良好的传统草药需要获得上市许可。本研究旨在确定民族医学证据对马里传统草药上市的贡献。
这是一项描述性横断面研究，于2023年12月至2024年3月进行，并辅以对马里和西非次区域传统医学相关立法和监管规定以及传统草药上市许可要求的文献综述。
马里上市许可的监管框架受2004年12月1日第04 - 557/P - RM号法令和2005年9月20日第05 - 2203/MS - MEP - SG号部际命令的管辖。这些文本根据类别规定了传统植物药上市许可的具体要求。它们将源自长期传统使用经验的民族医学证据视为2类传统药物疗效和耐受性的证明。结果，为15种源自传统医学和药典的产品颁发了上市许可，其中5种被列入马里基本药物国家清单和国家治疗处方集。
使用民族医学证据为源自传统医学的植物药获得上市许可提供了一个良好机会，而无需进行漫长且成本高昂的非临床和临床研究。
