International scientific guideline: ICH guideline Q8 (R2) on pharmaceutical development

About this guideline

TGA adopted date: 28 Feb 2020

Overseas effective date: 15 Jun 2006

Categories: Quality | Pharmaceutical development (quality)

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TGA annotations

This guideline is intended to provide specific guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) set out in the already adopted EU guideline - 'Common Technical Document for the Registration of Pharmaceuticals for Human Use - Quality (CPMP/ICH/2887/99 - Quality)'

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.