International scientific guideline: ICH topic Q3A (R2) - Note for guidance on impurities testing: Impurities in new drug substances

About this guideline

Overseas effective date: 1 Jun 2014

Replaces: CPMP/ICH/2737/99. ICH Topic Q 3 A (R) (Adopted by TGA 12 March 2003)

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.