ICH topic Q 3 A (R2) - Impurities in new drug substances

We have adopted this International Scientific Guideline – ICH Q3A (R2); CPMP/ICH/2737/99

Last updated

10 January 2025

About this guideline

Overseas effective date: October 2006

Replaces: CPMP/ICH/2737/99, ICH Topic Q 3 A (R1) (adopted by TGA 12 March 2003)

Categories: ICH | quality

Quality | Impurities

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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