International scientific guideline: Points to consider on switching between superiority and non-inferiority

About this guideline

Overseas effective date: 29 June 2001

Categories: Clinical efficacy and safety | Biostatistics

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TGA annotations

Please note that there is no requirement in Australia to demonstrate superiority.

For more information see International scientific guidelines adopted in Australia.

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.