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ICH-guideline-Q8-(R2)-on-pharmaceutical-development
[PDF, 593.48 KB]
About this guideline
Adopted by the TGA: 28 February 2020
Overseas effective date: May 2006
Categories: ICH | Quality
Quality | manufacturing
Quality | Pharmaceutical development
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)
- 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.
- All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency - external site for further information.
For more information see International scientific guidelines adopted in Australia.