Contribution of Ethnomedical Use Data to the Marketing Authorization of Traditional Herbal Medicines in Mali.

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.