ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals

We have adopted this International Scientific Guideline - ICH S1B(R1); EMA/774371/2022

Last updated

17 July 2024

About this guideline

Adopted by the TGA: 26 June 2024

Overseas effective date: 16 March 2023

Replaces: ICH S1B; CPMP/ICH/299/95

Categories: ICH | Safety | Carcinogenicity studies

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.
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