The success of the promotion policies of the Medicines Derived from Traditional Pharmacopoeia (MDTPs) requires a regulation that is adapted to realities and guarantees their quality, efficiency and safeness. This study aims to analyze the legal texts and the current guiding principles obtained from the heads of the departments in charge of traditional medicine in Burkina Faso and Benin. The documents collected from the two countries have been analyzed comparatively and also in relation to WAEMU regulations and the WHO recommendations. Several texts, dealing with the activity, products, facilities and advertisement related to traditional medicine, have been recorded in both countries. The regulation battery of Burkina Faso is more extensive than that of Benin, especially on traditional medicine and pharmacopoeia facilities. In addition, unlike biomedicines, the West African Economic and Monetary Union (WAEMU) and the West African Health Organization (WAHO) have not yet passed community laws on MDTPs. To limit disparities in legal frameworks between the countries of the same sub-region, it is important that the WAEMU or WAHO be involved in the harmonization of pharmaceutical regulations by setting Community rules in the domain.

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RESUME La persistance de fléaux, comme les pathologies dermatologiques de la dépigmentation volontaire en Afrique de l’Ouest, est un problème de santé publique dans le monde malgré toutes les mesures prises pour assurer la qualité des produits cosmétiques dans les pays. Cette étude a pour but de contribuer à l’amélioration de la règlementation sur les produits cosmétiques dans les pays à faible réglementation. Il s’est agi d’une étude transversale descriptive réalisée à travers une revue du cadre règlementaire de neufs pays/communauté. L’objectif principal est de décrire les exigences règlementaires relatives aux cosmétiques dans les pays. Comme variables, la définition, la classification, la fabrication, l’importation, la mise sur le marché, la surveillance du marché, l’utilisation et la cosmétovigilance. L’étude a montré qu’il existe une règlementation dans la majorité des pays depuis des années qui pour certains est communautaire (Europe, USA, Nigéria et UEMOA). Cependant, il faut noter une diversité des exigences dans les pays, une non disponibilité des risques d’expositions et des évaluations des ingrédients dans la majorité des pays ainsi qu’une insuffisance de contrôle et de cosmétovigilance qui constituent des insuffisances majeures pour la sécurité d’utilisation des cosmétiques. Les insuffisances règlementaires favorisent la circulation des cosmétiques de mauvaise qualité et contrefaits avec des conséquences néfastes pour la santé de nos populations.

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Introduction: Traditional medicine has become an important component in the care system of African populations. Many products derived from it are increasingly used in the therapeutic arsenal. This work is an inventory of the production of these drugs in two countries of West Africa, Burkina Faso and Benin. Methods: A cross-sectional descriptive study that listed the drug manufacturing units producing medicines derived from the traditional pharmacopoeia (MDTP) identified by the health ministries in the two countries was carried out. Results: Thirty-three production facilities, including 10 in Burkina Faso and 23 in Benin, were surveyed. Seven units surveyed in Burkina Faso and 16 in Benin were illegally installed. Only 16 of the 33 units obtain their raw materials from botanical gardens. The rest obtain theirs through picking which is not favorable to the perpetuation of the plant resource. In addition, among the 1041 MDTPs manufactured by the units surveyed, only 1.44% are registered. Finally, shortcomings in applying good practices for harvesting raw materials and manufacturing finished products were noticed. Conclusion: Management and capacity building efforts of MDTPs production facilities by political authorities are still needed to optimize the contribution of traditional medicine to the health care of African populations.