WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems
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World Health Organization
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18 p.
This publication provides technical guidance for the inclusion of herbal medicines in national pharmacovigilance systems. Developed in response to requests from WHO Member States and within the framework of the WHO International Drug Monitoring Programme, the guidelines address the growing global use of herbal medicines and the need to strengthen the monitoring, assessment and communication of adverse events associated with their use. The document outlines the principles of pharmacovigilance, describes the roles of national pharmacovigilance centres and regulatory authorities, and identifies challenges related to the regulation, quality assurance, classification and appropriate use of herbal medicines. The guidelines present practical approaches for the collection, reporting, assessment and management of safety information on herbal medicines, including recommendations on adverse reaction reporting, causality assessment, data management and signal detection. Particular attention is given to issues such as product quality, adulteration, contamination, incorrect identification of medicinal plants, interactions with other medicines and the involvement of a broad range of stakeholders, including health professionals, traditional medicine providers, manufacturers and consumers. The publication also emphasizes the importance of effective communication, international information exchange and capacity-building to promote the safe and proper use of herbal medicines and to strengthen public health protection.
This publication provides technical guidance for the inclusion of herbal medicines in national pharmacovigilance systems. Developed in response to requests from WHO Member States and within the framework of the WHO International Drug Monitoring Programme, the guidelines address the growing global use of herbal medicines and the need to strengthen the monitoring, assessment and communication of adverse events associated with their use. The document outlines the principles of pharmacovigilance, describes the roles of national pharmacovigilance centres and regulatory authorities, and identifies challenges related to the regulation, quality assurance, classification and appropriate use of herbal medicines. The guidelines present practical approaches for the collection, reporting, assessment and management of safety information on herbal medicines, including recommendations on adverse reaction reporting, causality assessment, data management and signal detection. Particular attention is given to issues such as product quality, adulteration, contamination, incorrect identification of medicinal plants, interactions with other medicines and the involvement of a broad range of stakeholders, including health professionals, traditional medicine providers, manufacturers and consumers. The publication also emphasizes the importance of effective communication, international information exchange and capacity-building to promote the safe and proper use of herbal medicines and to strengthen public health protection.