Module232025

07/05/2025

The ICH S11 guideline, implemented in 2020, does appear to be aiding drug developers in clarifying the need for additional animal studies, as well as in promoting a move away from toxicology studies with a conventional design. (Tavares et al. From guideline to practice: three years of ICH S11 insights and recommendations. Frontiers in Medicine, 2025, 12 DOI=10.3389/fmed.2025.1537001)

The Organisation for Professionals in Regulatory Affairs

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The review indicates that the implementation of ICH S11 facilitated science driven discussions about the necessity and design of JAS within the broader non-clinical strategy. A thorough consideration of developmental aspects of a product's pharmacological target, the clinical relevance of notable toxicity findings, and the clinical context of the medicine's use did fosters effective dialogue and improved regulatory alignment. The WoE approach in ICH S11 ensured that relevant safety information was generated to support paediatric drug development while balancing the principles of non-clinical replacement, reduction and refinement (the 3Rs).

The Organisation for Professionals in Regulatory Affairs

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