Module232025

07/05/2025

Prior to 2014, there were regional guidelines on the need for non-clinical testing in juvenile animals for pharmaceuticals for a paediatric indication, e.g. Europe (2008), USA FDA (2006) and Japan (2012). There was significant disharmony among these guidelines, leading to the adoption of ICH S11 in 2014.

The ICH S11 guideline was formally adopted in 2020.

The Organisation for Professionals in Regulatory Affairs

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The conduct of additional nonclinical investigations should be undertaken only when previous nonclinical and human data are judged to be insufficient to support paediatric studies . A JAS is designed to address safety concerns that cannot be adequately addressed in other nonclinical studies or paediatric clinical trials, including potential long-term safety effects. The ICH S11 guideline recommends a customised JAS that comprises core design endpoints and potential additional endpoints driven by specific concerns

The Organisation for Professionals in Regulatory Affairs

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