ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population

Addendum

We have adopted this International Scientific Guideline - ICH E11(R1); EMA/CPMP/ICH/2711/1999

Last updated

17 July 2024

Adopted by the TGA: 26 June 2024

Overseas effective date: 28 February 2018

Replaces: CPMP/ICH/2711/99

Categories: ICH | Efficacy | Clinical trials

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.
All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

Topics

Help us improve the Therapeutic Goods Administration site