International scientific guideline: ICH Topic Q3B (R2) - Note for guidance on impurities in new drug products

About this guideline

Overseas effective date: 1 May 2009

Replaces: CPMP/ICH/2736/99-ICH Q3B(R) (Adopted by TGA 16 August 2004)

Categories: Quality | Impurities | Nonclinical | General (nonclinical)

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For more information see International scientific guidelines adopted in Australia.

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.