The new ICH E11A guideline – an advantage for the development of herbal medicinal products for children?

There is still a shortage of medicines for children, even though the present European regulation [ 1 ] [ 2 ] was supposed to facilitate their development. However, the approval of herbal medicinal products (HMPs) for children has become more tempting. Today, it has become clear that the aim must be to avoid large, placebo-controlled clinical trials in children wherever possible. With the guideline for pediatric extrapolation (E11A) [ 3 ] [ 4 ] published on August 27, 2024, there is now a binding guideline for the extrapolation from adult to pediatric patients. The new guideline was systematically analyzed with regard to the extent to which it can facilitate the approval of HMPs for children. Three questions are addressed in the guideline: How similar are (1) the disease, (2) the pharmacology of the drug, and (3) the response to therapy in adults and pediatric patients? The pediatric extrapolation is considered as a continuum: Accordingly, if there are major differences between adults and children, more data are required. A pediatric extrapolation plan is then derived, which lists any necessary studies. Here particular emphasis lays on the use of pharmacokinetic data, but also real world data (RWD) are in scope. While for most HMPs, but also for locally acting preparations and vaccines, no pharmacokinetic data can be collected, refering to the similarities between adults and children can be a way forward [ 4 ]. For this, also RWD can be a support. This underlines the importance of GA’s initiatives to give more weight to RWD in pediatric extrapolation [ 2 ] [ 5 ]. Overall, the new guideline may give cause for optimism. Publication History Article published online: 05 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany