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About this guideline
Overseas effective date: 1 February 2001
Categories: Clinical efficacy and safety | Biostatistics
TGA annotations:
Please note that there is no requirement in Australia to demonstrate superiority.
- 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.