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About this guideline
Adopted by the TGA: 1 August 2025
Overseas effective date: 30/07/2020
Categories: Clinical efficacy and safety | Biostatistics
ICH | efficacy
TGA annotations: This guideline does not apply to listed medicines, assessed listed medicines and registered complementary medicines.
- 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.