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ICH guideline M3 (R2) - questions and answers

We have adopted this International Scientific Guideline – ICH M3 (R2 ) Q&As; EMA/CHMP/ICH/507008/2011

Last updated

About this guideline

For information: May 2012

Note: This document clarifies key issues in ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals.

Categories: ICH | Multidisciplinary

Nonclinical development 

TGA annotations: Nil

 

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For more information see International scientific guidelines adopted in Australia.

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