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About this guideline
Adopted by the TGA: 13 March 2025
Overseas effective date: 14 March 2023
Categories: ICH | Safety
Multidisciplinary | Gene therapy
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.
- All documents and other content published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) on this website are under the copyright and other intellectual property rights ownership of the ICH. Please refer to ICH Official web site : ICH for further information.
For more information see International scientific guidelines adopted in Australia.