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ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals

We have adopted this International Scientific Guideline – ICH M2(R2); EMA/CPMP/ICH/286/1995 

Last updated

About this guideline

Overseas effective date: December 2009

Replaces: CPMP/ICH/286/95 Modification (adopted by TGA 17 December 2010)

Note: Please refer to ICH guideline M3 (R2) - questions and answers for further clarification of key issues. 

Categories: ICH | Multidisciplinary

Non-clinical 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.

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