International scientific guideline: Points to consider on application with 1. meta-analyses; 2. one pivotal study

About this guideline

Overseas effective date: 27 March 2002

Categories: Clinical efficacy and safety | Biostatistics

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TGA annotations

Sponsors are reminded that they should submit all available new safety data that are relevant to the intended treatment population.

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.