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About this guideline
Overseas effective date: May 2010
Note: This should be read together with ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals - questions and answers (ICH S9 Q&As; EMA/CHMP/ICH/453684/2016)
Categories: ICH | Safety
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.