Module232025

07/05/2025

The most important factors that should be highly weighted (listed first) are the youngest intended patient age and whether there are suspected adverse effects on developing organ systems of the patients during the conduct of the paediatric trial. The other factors are not listed in order of importance.

Taken from ICH S11

The Organisation for Professionals in Regulatory Affairs

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The youngest intended patient age is one of the most important factors to be considered. As stated in ICH E11, any classification of the paediatric population into age categories is to some extent arbitrary, but a classification, such as the one in the figure from ICH S11 provides a basis for thinking about the nonclinical testing to support safety in such patients. Decisions on how to stratify by age should focus on developmental biology. Additional nonclinical studies are more likely to be warranted to support younger paediatric age ranges.

The Organisation for Professionals in Regulatory Affairs

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