Data Recommendations for Paediatric Phytomedicines

The European Medicines Agency (EMA) recently published a reflection paper on data recommendations for herbal medicinal products (HMPs) used in paediatric patients, along with a summary of the comments received on the draft version, which was published last year.

Background

The document aims to provide basic recommendations for establishment of European Union herbal monographs with a paediatric indication. These recommendations can be applied by the national competent authorities, by analogy, in the assessment of applications for (traditional) herbal medicinal products (HMPs) or by applicants preparing application dossiers.

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 "Traditional Use" (TU) and "Well established Use" (WEU) applications, especially for clinical data.

HMPs indicated for paediatric patients should be age-appropriate ensuring that patients in the target age group will have access to medicinal products with a consistent quality and safety with adequate patient adherence.

The principles laid out in the "ICH E11A Guideline on paediatric extrapolation" may be useful when considering whether alternative sources of data, e.g. real-world data (RWD), might in some circumstances help to perform the benefit-risk assessment for an HMP in the paediatric population.

For more information please see the "Reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in paediatric patients" together with the "Overview of comments on draft reflection paper" published on the EMA Website.