Paediatric Use of Herbal Medicinal Products: New Insights in RWD Generation - A Report on the RWD Workshop 2025 in
Nico Symma1, Andreas Hensel2,3, Bernd Roether4,3
1Pharma Deutschland e. V., Bonn, Germany.
Insights
Generating real-world data (RWD) for herbal medicines in children is efficient. New data sources can support rationalizing pediatric use of these products, requiring regulatory engagement for broader application.
Area of Science:
- Pharmacovigilance
- Paediatric Pharmacology
- Real-World Evidence
Background:
- Herbal medicinal products (HMPs) are common in European pediatric practice, yet formal authorizations for children are scarce.
- Limited formal authorization hinders the rational use of HMPs in pediatric populations.
Purpose of the Study:
- To present updates on real-world data (RWD) and real-world evidence (RWE) activities for rationalizing HMP use in children.
- To discuss novel data sources and epidemiological methods for pediatric HMP research.
Main Methods:
- Workshop presentations on recent activities in RWD/RWE for pediatric HMPs.
- Discussion of new data sources: insurance claims, patient-reported outcomes, social media surveys.
- Application of modern epidemiological methods to analyze RWD.
Main Results:
- Decision-relevant pediatric data on HMP usage can be efficiently generated through new RWD sources.
- Identified concrete new data sources including insurance claims, patient cohorts, and social media surveys.
- Demonstrated the feasibility of generating valuable RWD for pediatric HMP use.
Conclusions:
- Establishing new RWD data sources is an efficient strategy for generating decision-relevant pediatric data on HMPs.
- Engaging with regulators is a necessary next step to enable the use of these data pools in regulatory practice.
- Future research should focus on integrating these novel data sources into regulatory frameworks for pediatric HMP authorization.
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.
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