The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
About this guideline
Overseas effective date: January 2006
Note: See also ICH guideline Q8, Q9 and Q10 – questions and answers volume 4 (ICH Qs8-10 Q&As Volume 4; EMA/CHMP/ICH/265145/2009)
Categories: ICH | Quality
Quality | Manufacturing
Quality | Pharmaceutical
- 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.