Europe – Draft ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines – Overview of comments received

The ICAPPP appreciates the idea behind this guideline, which aims to provide
internationally harmonised guidance on the nonclinical studies recommended to
support the development of paediatric medicines.
However, considering that one of the stated key objectives of the guideline is to
promote a reduction in the use of animals in accordance with the 3Rs principles, we
have some serious concerns regarding; 1) the lack of examples and limited guidance
provided on nonclinical testing methods other than juvenile animal studies (JAS), and
2) the unsubstantiated support for JAS as a standard approach, rather than as a last
resort option.
We urge against JAS studies being performed as a ‘tick-box’ exercise or default option
for addressing safety concerns. Considering that the data generated may be of little
relevance, the use of the JAS method (especially routinely) could be considered
unethical as it may provide false reassurance regarding safety but will certainly cause
significant suffering of animals…