La EMA abre a la consulta pública un documento de reflexión sobre recomendaciones para el uso medicamentos a base de plantas en niños y adolescentes

EMA has released for public consultation a new reflection paper, 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 used in children and adolescents for minor but common problems such as upper respiratory tract infections, gastrointestinal disorders, skin problems, sleep disorders, loss of appetite or urinary tract disorders. A number of European Union (EU) herbal monographs for both traditional use (TU) and well-established use (WEU) have been issued by the Committee on Herbal Medicinal Products (HMPC) that include a paediatric population within the indication(s).

The inclusion of a paediatric population into the indication(s) of an EU herbal monograph with a specified posology of a herbal substance/preparation, the decisions on contraindications and special warnings, etc. have been based on actual documented use of a (T)HMP in the specific paediatric population, supported by published historical and recent bibliographic/expert evidence and/or data from clinical studies conducted with the targeted paediatric population. The HMPC compiled a list summarising the existing indications and any limitations of (T)HMPs use in children, i.e. 'European Union herbal monographs: Overview of recommendations for the uses of herbal medicinal products in the paediatric population’ (EMA/HMPC/228356/2012 Rev. 2).

While the herbal legislation for THMPs (Art. 16a Directive 2001/83/EC) does not make any distinction between adults and children, i.e. requirements on TU in the paediatric population and on specific data are the same as for adults, data from clinical studies conducted in paediatric population on herbal medicinal products (Art. 10a of Directive 2001/83/EC) are often very limited. Efforts were made by the HMPC in recent years to promote data generation from paediatric clinical studies and to discuss use of extrapolation.

The HMPC describes in its ‘Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population’ (EMA/HMPC/833398/2009) three approaches to be followed in order to stimulate research in this field to allow the correct use of HMPs, as
follows:

- Identification of herbal substances/herbal preparations for which a therapeutic benefit is expected (HMPC and PDCO should identify appropriate criteria to select them).

- Provision of guidelines and recommendations for developing appropriate paediatric studies for HMPs.

- Promotion of funding to collect more data on monitoring safe use in children and to stimulate further research.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published a harmonised E11A guideline on paediatric extrapolation in 2024. The purpose of this guideline is to provide recommendations for, and promote international harmonisation of, the use of paediatric extrapolation to support the development and authorisation of paediatric medicines. This guideline deals with medicinal products with defined pharmacokinetics and pharmacodynamics and does not explicitly mention that it can be considered for the purpose of HMPs containing herbal substances/preparations that are complex mixtures of constituents with different properties.

This new reflection paper aims to provide basic recommendations for establishment of EU herbal monographs with a paediatric indication by the HMPC. These recommendations can be applied by analogy by the national competent authority (NCA) when assessing (T)HMP dossiers or by applicants Reflection paper on data recommendations for traditional herbal medicinal product and herbal medicinal products used in children and adolescents EMA/HMPC/71333/2023 compiling dossiers of (T)HMPs. Major aspects to be considered are the differences in organ systems maturity and related changes in pharmacological properties of herbal substances/preparations, available efficacy and safety data, suitability of a pharmaceutical form, and legal provisions to be fulfilled for both TU and WEU applications, especially for clinical data.

The reflection paper is open for consultation until 31 August 2025. Comments should be provided using this template and sent to hmpc.secretariat@ema.europa.eu.

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