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-evaluation-of-stability-data
[PDF, 266.89 KB]
About this guideline
Overseas effective date: August 2003
Categories: ICH | Quality
Quality | Stability
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 European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency - external site for further information.
For more information see International scientific guidelines adopted in Australia.