In Cuba, Herbal Medicine is part of the Natural and Traditional Medicine system and is regulated by CECMED, a WHO-recognized agency. The regulatory framework includes four main norms covering product authorization, GMP, and licensing for local production. Registration requires: - Full data for new products; simplified process for known ones. - Info on cultivation, plant parts, composition, safety, efficacy, and clinical use. - Integration of good practices (agricultural, manufacturing, clinical) ensures quality and consistency.