The European Medicines Agency (EMA) has opened a public consultation on the “Reflection Paper on Data Recommendations for Herbal Medicinal Products and Traditional Herbal Medicinal Products Used in Children and Adolescents”.
Herbal medicinal products (HMPs) and traditional herbal medicinal products (THMPs) are commonly used to address minor but frequent health issues in paediatric populations, such as upper respiratory tract infections, gastrointestinal disturbances, skin conditions, sleep problems, appetite loss, and urinary tract disorders.
Despite that, clinical data on the safety and efficacy of these products in children and adolescents remain limited. In recent years, the Committee on Herbal Medicinal Products (HMPC) has actively encouraged the generation of paediatric clinical data and discuss about the use of the extrapolation.
The newly published reflection paper offers baseline recommendations to support the development of EU herbal monographs for paediatric indications. It outlines key considerations for marketing authorisation applications, including:
• Quality, composition, and formulation-specific aspects
• Clinical and non-clinical data requirements
You can provide your feedback during the consultation period, which is open until 31 August 2025, on this page.