ICH Topic Q 3 B (R2) - Impurities in new drug products

We have adopted this International Scientific Guideline – ICH Q3B (R2); CPMP/ICH/2738/99

Last updated

13 January 2025

About this guideline

Overseas effective date: June 2006

Replaces: CPMP/ICH/2736/99; ICH Q3B (R1) (adopted by TGA 16 August 2004)

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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