Abstract
“Children are not small adults with respect to the treatment with medicinal products.”
This statement of the WHO was the basis for the initiative of the European Commission
for the establishment of a paediatric regulation in 2007 to improve the health of
children by facilitating the development of medicines for children and adolescents.
Seventeen years later, in the field of herbal medicinal products, results are still
sobering. Therefore, the Foundation Plants for Health, Society for Medicinal Plants
and Natural Products Research, and German Society for Phytotherapy organised a symposium
to assess the status quo for the paediatric use of herbal medicinal products (HMPs),
to analyse the causes of the current situation, and to discuss strategies for establishing
the proof of safe and efficacious HMPs for children.
The current situation for HMPs and their use in children is not fulfilling the requirements
of legislation. HMPs in paediatrics are effective and safe, but considering the needs
of children is necessary. In European countries, the use, registration, and marketing
of HMPs are different, depending on the respective national regulations and specific
traditions. EU herbal monographs are the best common denominator for such procedures.
Emerging safety discussions must be considered. New approaches with real-world data
might be a solution. The regulatory framework is to be adapted. Defining rationalised
dosing for HMPs can be achieved by the extrapolation of data from adults, by using
existing clinical data for children, and by using RWD. Therefore, a strong need for
revising restrictions for the use of HMPs in children and rationalising defined dosage
regimes is obvious.
Keywords
children - dosage - extrapolation - herbal medicinal products - phytotherapeutics
- real world data
