We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
About this guideline
Overseas effective date: June 2008
Categories: ICH | Quality
Quality | Specifications and analytical procedures and analytical validation
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 for further information.
For more information see International scientific guidelines adopted in Australia.