ICH S9 Q&As non-clinical evaluation for anticancer pharmaceuticals - Questions and answers (Step 2b)

We have adopted this International Scientific Guideline – ICH S9 Q&As; EMA/CHMP/ICH/453684/2016

Last updated

12 December 2024

About this guideline

Adopted by the TGA: 28 February 2020

Overseas effective date: 28 January 2017

Note: This document is intended to provide additional clarification relating to the selection and justification of starting materials; and should be read together with ICH guideline S9 on non-clinical evaluation for anticancer pharmaceuticals (ICH S9; EMA/CHMP/ICH/646107/2008)

Categories: ICH | Safety

Non-clinical development

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.
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.

Product types

Topics