ICH guideline E8 (R1) on general considerations for clinical studies

We have adopted this International Scientific Guideline - ICH E8 (R1); EMA/CHMP/ICH/544570/1998 Corr*

Last updated

29 August 2024

About this guideline

Adopted by the TGA: 26 June 2024

Overseas effective date: 14 April 2022

Replaces: ICH E8; CPMP/ICH/291/95

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.

Product types

Topics