From guideline to practice: three years of ICH S11 insights and recommendations.

ABSTRACT: Juvenile Animal Studies (JAS) may be warranted to ensure the safe clinical use of medicines for children. The ICH S11 guideline was developed to guide the need for and design of JAS, and proposes a weight-of-evidence (WoE) approach. We evaluated how the introduction of the guideline shaped the non-clinical strategy for paediatric medicines in the European Union. Our review included Paediatric Investigation Plans (PIPs) for 127 products approved between 2020 and 2023, along with the associated regulatory assessment and final non-clinical plans. Although in 12 of selected PIPs a JAS was already ongoing or completed at the time of submission, in all other cases (115/127), the PIP was submitted before the initiation of JAS. In 75% (86/115) of these procedures the discussions based on the ICH S

SUBMITTER: Tavares D 

PROVIDER: S-EPMC11847842 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature