ICH S5 (R2) reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals

Current version

PDF iconRevision 2 - Adopted guideline

Currently under revision - see below

Reference numberCPMP/ICH/386/95
Published30/09/1993
Effective from01/03/1994
KeywordsReproductive toxicity, selection of species, study design, fertility, embryo-fetal development, prenatal development, postnatal development
DescriptionThis document gives recommendations on the strategy of reproductive toxicity testing of chemicals and medicinal products. It also addresses the male fertility investigation.


Document history

Revision 3

In progress

PDF iconDraft guideline

PDF iconOverview of comments

Published: 31/09/2017

Published: 26/04/2018

Revision 2

Current version

PDF iconAdopted guideline

Published: 30/09/1993

In operation: 01/03/1994-present


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