A global approach to safety assessment of medicinal plants
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World Health Organization
Abstract
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3 p.
The growing global use of medicinal plants, alongside fragmented regulatory frameworks and divergent classification approaches across countries, raises significant challenges for ensuring their safety in diverse health systems. This perspective article examines the limitations of current approaches to safety assessment, which often rely on models developed for synthetic pharmaceuticals and may inadequately reflect the complexity, variability and contextual nature of plant-based therapies. It outlines key factors influencing safety, including traditional knowledge, ecological conditions, preparation methods, dosage and concurrent use with other substances, and highlights the importance of distinguishing between traditional and novel uses, as well as the role of historically presumed safety based on long-standing use. The article presents a comprehensive and integrative approach to safety evaluation that combines traditional use evidence, real-world data, pharmacovigilance and modern scientific methods such as toxicogenomics and artificial intelligence. It identifies gaps in existing regulatory and research frameworks and proposes the development of a globally coordinated system, including a centralized knowledge hub to support data sharing, standardization and policy guidance. Strengthening interdisciplinary collaboration and aligning diverse evidence sources are emphasized as essential steps to improve safety assessment, inform regulation and support equitable access to safe and effective medicinal plant use worldwide.
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743
The growing global use of medicinal plants, alongside fragmented regulatory frameworks and divergent classification approaches across countries, raises significant challenges for ensuring their safety in diverse health systems. This perspective article examines the limitations of current approaches to safety assessment, which often rely on models developed for synthetic pharmaceuticals and may inadequately reflect the complexity, variability and contextual nature of plant-based therapies. It outlines key factors influencing safety, including traditional knowledge, ecological conditions, preparation methods, dosage and concurrent use with other substances, and highlights the importance of distinguishing between traditional and novel uses, as well as the role of historically presumed safety based on long-standing use. The article presents a comprehensive and integrative approach to safety evaluation that combines traditional use evidence, real-world data, pharmacovigilance and modern scientific methods such as toxicogenomics and artificial intelligence. It identifies gaps in existing regulatory and research frameworks and proposes the development of a globally coordinated system, including a centralized knowledge hub to support data sharing, standardization and policy guidance. Strengthening interdisciplinary collaboration and aligning diverse evidence sources are emphasized as essential steps to improve safety assessment, inform regulation and support equitable access to safe and effective medicinal plant use worldwide.
741
743