EMA Reflection Paper on Data Recommendations for Herbal Medicinal Products

The European Medicines Agency (EMA) published a draft "Reflection paper on data recommendations for herbal medicinal products (HMPs) and traditional herbal medicinal products (THMPs) used in children and adolescents". The paper is open for a 3-month public consultation until 31 August 2025.

Background

The ICH E11A guideline provides recommendations for the use of paediatric extrapolation to support the development and authorization of paediatric medicines. However, 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. Therefore, the reflection paper aims to provide basic recommendations for establishment of EU herbal monographs with a paediatric indication. These recommendations can be applied also by the national competent authority (NCA) when assessing THMP dossiers or by applicants compiling dossiers of THMPs. 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 pharmaceutical forms, and
• Legal provisions to be fulfilled for both TU (Traditional Use) and WEU (Well-established Use) applications.

Use of Real-World Data (RWD)

In specific cases, Real-World Data (RWD) can support the assessment process. The data collected should be sufficiently robust. Collecting of data from different source groups may improve its reliability. The focus should be on collecting information on the size of the exposed population, age, symptoms/diagnosis, product type, dosage, treatment outcome, tolerability and duration of use. It is also important to understand that these data may be significantly limited in terms of quality and may only be supportive. For example, it can be difficult to collect data covering the last 30 years sufficiently (e.g., for traditional use). Prospective collection of RWD could be considered where possible, and aspects of this collection should ideally be discussed in advance with regulators.

More information is available in the draft Reflection Paper published on the EMA website.