WHO Guidelines for Herbal Medicines

The World Health Organization maintains a coherent body of technical guidance that underlies much of the national regulatory framework described above, and provides the reference standard against which herbal drug quality, safety, and traditional-use evidence are internationally assessed. The WHO General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine, first issued in 2000, establishes the overarching conceptual framework for assessing the safety, quality, and efficacy of traditional medicines, and is a core reference underlying AYUSH regulatory submissions. WHO's guidance on safety monitoring of herbal medicines within pharmacovigilance systems establishes the framework for post-marketing adverse drug reaction reporting specific to herbal products, recognising that herb-drug interactions and quality-related adverse events present distinct pharmacovigilance challenges relative to synthetic medicines. The WHO Prequalification of Medicines Programme additionally provides a pathway through which herbal products intended for procurement by United Nations agencies undergo GMP inspection and product dossier review, a route of particular relevance to herbal manufacturers targeting international export markets.