ICH guideline Q8, Q9 and Q10 - questions and answers volume 4

We have adopted this International Scientific Guideline – ICH Q8, Q9 & Q10 Q&As (volume 4); EMA/CHMP/ICH/265145/2009

Last updated

12 November 2024

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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