ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - Scientific guideline

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.

Current version

ICH S5 (R3) guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - step 5 - Revision 4

Adopted Reference Number: EMA/CHMP/ICH/544278/1998 Legal effective date: 30/07/2020

Document history

Draft ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals, step 2b - Revision 3

Draft: consultation closed Consultation dates: 31/08/2017 to 28/02/2018 Reference Number: EMA/CHMP/ICH/544278/1998 Summary:

The purpose of this guideline is to provide key considerations for developing a testing strategy to identify hazard and characterize reproductive risk for human pharmaceuticals. The guidance informs on the use of existing data and identifies potential study designs to supplement available data to identify, assess, and convey risk.

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

Reference Number: EMA/181369/2018 Summary:

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)

ICH: S 5 (R2): Detection of toxicity to reproduction for medicinal products & toxicity to male fertility - Step 5 - Revision 2

Adopted Reference Number: CPMP/ICH/386/95 Legal effective date: 01/03/1994