ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5 - Scientific guideline

The S11 guideline is proposed to provide direction on the nonclinical safety studies important to support a paediatric development program. It will recommend standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support paediatric clinical trials, and also provide guidance on the design of the studies. A streamlined drug development and higher scientific rigor while minimizing the unnecessary use of animals will be achieved with the implementation of this new harmonised ICH guideline.

Keywords: nonclinical safety, testing, paediatric medicines, weight of evidence approach

Current version

ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5

AdoptedReference Number: EMA/CHMP/ICH/616110/2018Legal effective date: 26/09/2020

Document history

ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5

AdoptedReference Number: EMA/CHMP/ICH/616110/2018Legal effective date: 26/09/2020

ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines - Step 2b - Draft guideline

Draft: consultation closedConsultation dates: 24/09/2018 to 24/03/2019Reference Number: EMA/CHMP/ICH/616110/2018

Overview of comments received on draft ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines (EMA/CHMP/ICH/616110/2018)

Reference Number: EMA/213997/2019