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About this guideline
Overseas effective date: September 1998
Note: This should be read together with ICH: E 5 (R1): Questions & answers ethnic factors in the acceptability of foreign clinical data (ICH E5 (R1) Q&As; CHMP/ICH/5746/03)
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.