International scientific guideline: ICH guideline Q9 on quality risk management

About this guideline

Overseas effective date: 25 May 2015

Categories: Quality | Pharmaceutical development (quality)

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Further information

See also EMA/CHMP/ICH/265145/2009 questions and answers on the guideline

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.