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ICH-guideline-q8-q9-and-q10-questions-and-answers-volume-4
[PDF, 173.48 KB]
About this guideline
For information: December 2010
Replaces: May 2009 version (provided for information May 2010)
Note: See also ICH guideline Q10 on pharmaceutical quality system (ICH Q10; EMA/CHMP/ICH/214732/2007)
Categories: ICH | Quality
Quality | Manufacturing
Quality | Pharmaceutical development
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.