ICH guideline Q3D (R2) on elemental impurities

We have adopted this International Scientific Guideline - ICH Q3D (R2); EMA/CHMP/ICH/353369/2013

Last updated

17 July 2024

About this guideline

Adopted by the TGA: 26 June 2024

Overseas effective date: 24 September 2022

Replaces: ICH Q3D (R1); EMA/CHMP/ICH/353369/2013 (adopted by the TGA on 15 July 2019).

Categories: ICH | 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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