ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals - step 5
This document gives recommendations on the strategy of reproductive toxicity testing of chemicals and medicinal products. It also addresses the male fertility investigation.
Keywords: Reproductive toxicity, selection of species, study design, fertility, embryo-fetal development, prenatal development, postnatal development.
Draft ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals, step 2b - Revision 3 (PDF/1.1 MB)Draft: consultation closed
First published: 31/08/2017
Last updated: 31/08/2017
Consultation dates: 31/08/2017 to 28/02/2018
Overview of comments received on ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals (EMA/CHMP/ICH/544278/1998) - Revision 3 (PDF/439.55 KB)
First published: 26/04/2018
Last updated: 26/04/2018
ICH: S 5 (R2): Detection of toxicity to reproduction for medicinal products & toxicity to male fertility - Step 5 - Revision 2 (PDF/264.86 KB)Adopted
First published: 30/09/1993
Last updated: 30/09/1993
Legal effective date: 01/03/1994