International scientific guideline: Reflection paper on the use of extrapolation in the development of medicines for paediatrics

About this guideline

TGA adopted date: 15 Jul 2019

Overseas effective date: 17 Oct 2018

Categories: Clinical efficacy and safety | General (clinical)

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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.