ICH Topic S8 - Immunotoxicity studies for human pharmaceuticals

We have adopted this International Scientific Guideline – ICH S8; CHMP/167235/2004

Last updated

13 January 2025

About this guideline

Overseas effective date: May 2006

Categories: ICH | Safety

Non-clinical | Toxicology | Immunotoxicity

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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