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ICH guideline Q8 (R2) on pharmaceutical development

We have adopted this International Scientific Guideline – ICH Q8 (R2); EMA/CHMP/ICH/167068/2004 

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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 for further information.

For more information see International scientific guidelines adopted in Australia.

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