Topic overview

Start with the big picture

The lesson outlines WHO guidance for integrating herbal adverse drug reactions into national pharmacovigilance systems, standardizing botanical nomenclature, and applying good manufacturing practices. It then examines the US distinction between most herbal dietary supplements and products making therapeutic claims, alongside manufacturing, labeling, and adverse-event reporting requirements. For the EU, it introduces the traditional-use and well-established-use routes under Directive 2004/24/EC, as well as pharmacovigilance and herbal quality standards. Across these frameworks, the central regulatory challenge is to connect accurate ingredient identification and controlled production with evidence appropriate to a product’s claims and continued monitoring after market entry.