The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
About this guideline
Adopted by the TGA: 08 June 2023
Overseas effective date: 30 July 2020
Replaces: CPMP/ICH/386/95 - ICH Topic S 5 (R2)
Categories: ICH | Safety
Non-clinical | Toxicology | Reproductive/developmental and juvenile toxicity
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.