ICH harmonised guideline - Nonclinical safety testing in support of development of paediatric pharmaceuticals

We have adopted this International Scientific Guideline- ICH S11

Last updated

17 July 2024

About this guideline

Adopted by the TGA: 26 June 2024

Overseas adoption date: 14 April 2020

Categories: ICH | Safety | Nonclinical safety in paediatric medicines

TGA annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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