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ICH_guideline_E3_-_questions_and_answers_R1
[PDF, 179.5 KB]
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: 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.