Paediatric Use of Herbal Medicinal Products: New Insights in RWD Generation – A Report on the RWD Workshop 2025 in Naples

Abstract Herbal medicinal products (HMPs) are widely used in European paediatric practice, but formal authorisations for their use in children remain limited. Following the 2024 workshop in Krakow, the Foundation Plants for Health (FPfH) organised a further workshop in Naples on 31 August 2025 as part of the 73rd International Congress and Annual Meeting of the Society for Medicinal Plant and Natural Product Research (GA) to present updates of recent activities in the field of real-world data (RWD) and real-world evidence (RWE) for rationalising the usage of herbal medicines in children. Speakers presented concrete new data sources – private health insurance claims, patient reported outcome cohorts, and a social-media-based user survey – as well as modern methods in epidemiology. The workshop concluded that decision-relevant paediatric data on the use of HMPs can be generated efficiently by establishing new RWD data sources. For the subsequent next steps, it is necessary to engage with regulators to open usage of these data pools in regulatory practice.