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About this guideline
Adopted by the TGA: 26 June 2024
Overseas effective date: 16 March 2023
Replaces: ICH S1B; CPMP/ICH/299/95
Categories: ICH | Safety | Carcinogenicity studies
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.