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

  • Email
  • Help

Document details

Download document Draft ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals, step 2b - Revision 3
Reference number EMA/CHMP/ICH/544278/1998
Status draft: consultation open
First published 2017-08-31
Last updated 2017-08-31
Consultation start date 2017-08-31
Consultation end date 2018-02-28
Email address for submissions ich@ema.europa.eu

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.