ICH guideline E3 - questions and answers (R1)

We have adopted this International Scientific Guideline – ICH E3 Q&As (R1); EMA/CHMP/ICH/435606/2012

Last updated

20 February 2025

About this guideline

For information: July 2012

Note: This document clarifies key issues in ICH topic E 3: structure and content of clinical study reports

Categories: ICH | Efficacy

Clinical efficacy and safety | General

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