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ICH-guideline-m3-r2-questions-and-answers
[PDF, 210.37 KB]
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
- 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.