Module232025

07/05/2025

It can still be appropriate to evaluate the potential impact on paediatric subjects of a toxicity that occurred in adult animals that did not appear to translate to adverse effects in adult humans, if the target organ/system is undergoing development in the relevant paediatric population. Depending on the age of the animals at initiation of dosing and the endpoints included, some of these concerns may have been addressed in existing toxicity studies and a JAS may not be warranted. Additional genotoxicity and safety pharmacology assessments in juvenile animals are generally not appropriate to support paediatric indications.

The Organisation for Professionals in Regulatory Affairs

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Reproductive and developmental toxicity study data may also be available and can be informative. If PPND/ePPND study data are available and have shown clinically relevant systemic exposures in offspring during the postnatal period, these data can contribute to the WoE evaluation. Observations of adverse effects in offspring would not, on their own, indicate that a JAS is recommended.

The Organisation for Professionals in Regulatory Affairs

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