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About this guideline
Adopted by the TGA: 26 June 2024
Overseas effective date: 30 September 2023
Replaces: ICH M7 (R1); EMA/CHMP/ICH/83812/2013 (adopted by the TGA on 20 February 2020).
Categories: ICH | Multidisciplinary
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.