Reflection paper on the use of extrapolation in the development of medicines for paediatrics

We have adopted this International Scientific Guideline - EMA/189724/2018

Last updated

20 February 2025

Adopted by the TGA: 15 July 2019

Overseas effective date: 17 October 2018

Replaces: Concept paper on extrapolation of efficacy and safety in medicine development (EMA/129698/2012)

Categories: Multidisciplinary | Paediatrics

TGA Annotations: Nil

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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