Concept paper on extrapolation of efficacy and safety in medicine development

We have adopted this International Scientific Guideline - EMA/129698/2012.

Last updated

3 June 2024

About this guideline

End of consultation (overseas): 30 September 2012

Categories: Clinical efficacy and safety | Biostatistics

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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