The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Note-for-guidance-on-impurities-in-new-drug-products
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About this guideline
Overseas effective date: June 2006
Replaces: CPMP/ICH/2736/99; ICH Q3B (R1) (adopted by TGA 16 August 2004)
Categories: ICH | quality
Quality | Impurities
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.