We are aware of an issue causing the title of some ARTG entries to disappear. We are investigating as a priority and hope to have this resolved as soon as possible.
ICH-guideline-Q9-on-quality-risk-management
[PDF, 70.1 KB]
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.
- 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.