International scientific guideline: ICH S9 Q&As nonclinical evaluation for anticancer pharmaceuticals - Questions and answers

About this guideline

TGA adopted date: 28 Feb 2020

Overseas effective date: 16 Nov 2018

Categories: Clinical efficacy and safety | Antineoplastic and immunomodulating agents

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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.