You are here Home Guidance and resources Resources International scientific guidelines adopted in Australia International scientific guideline: ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals EMA/CHMP/ICH/544278/1998 Listen Print Share LinkedIn (Twitter) Facebook Email Loading... About this guideline Adopted by the TGA: 08 June 2023 Overseas effective date: 30 July 2020 Replaces: CPMP/ICH/386/95 - ICH Topic S 5 (R2) Categories: Nonclinical | Toxicology | Reproductive and developmental toxicity Access this international scientific guideline 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.
