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ICH-topic-E-3-structure-and-content-of-clinical-study-reports
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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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For more information see International scientific guidelines adopted in Australia.