ICH topic E 3: structure and content of clinical study reports

We have adopted this International Scientific Guideline – ICH E3; CPMP/ICH/137/95

Last updated

29 August 2024

About this guideline

Overseas effective date: July 1996

Note: Please refer to ICH guideline E3 - questions and answers (R1) [ICH E3 Q&As (R1); EMA/CHMP/ICH/435606/2012] for further clarification of key issues.

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.
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