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Guideline on clinical trials in small populations

We have adopted this International Scientific Guideline - CHMP/EWP/83561/2005.

Last updated

About this guideline

Overseas effective date:  1 February 2007

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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For more information see International scientific guidelines adopted in Australia.

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This webpage on the TGA website was printed on 12 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/international-scientific-guidelines/guideline-clinical-trials-small-populations

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