Improved traditional medicines in Mali.

Abstract

Mali is unusual in enjoying a high level of government support for research and development of traditional medicines. The Department for Traditional Medicine, within the National Institute for Research on Public Health (part of the Ministry of Health), was founded in 1968 (originally as the National Institute of Phytotherapy and Traditional Medicine), and in 2005 moved to new purpose-built premises. Since 1979, one of its aims has been the development of standardized “Medicaments Traditionnels Ameliores” (MTAs, or improved traditional medicines). The “improvement” lies in the pharmacologic evidence of safety and efficacy, the standardized dose and quality control. In order to obtain marketing authorization, a dossier of information on the remedy's safety and efficacy must be submitted to the Commission Nationale d'Autorisation de Mise sur le Marche of the Ministry of Health. Malian regulations categorize traditional medicines as shown in Table 1.1 The requirements for the dossier vary according to the category (Table 2). Most MTAs are of category 2, for which clinical trials are not an absolute requirement. Table 1. Categories of Traditional Medicines in Malian Law1