Points to consider on switching between superiority and non-inferiority

We have adopted this International Scientific Guideline - CPMP/EWP/482/99

Last updated

19 December 2024

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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