4 September 2017

The ICH S5(R3) on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 2b of the ICH Process in August 2017 and now enters the consultation period.

Since the implementation of the previous version of the S5 Guideline i.e S5(R2) on Reproductive Toxicity, not only has experience been gained with the testing of pharmaceuticals using the current and novel testing paradigms; but scientific, technological and regulatory knowledge has also significantly evolved. Consequently there were opportunities for modernising testing paradigms to enhance human risk assessment, while also potentially reducing animal use. The ICH S5(R3) provides human safety assurance at least equivalent to that provided by current testing paradigms.

The ICH S5(R3) draft Guideline can be downloaded on the Safety Guideline page on the ICH website.

You may provide comments on the ICH S5(R3) draft Guideline document by e-mailing the ICH Secretariat. More details under the Public Consultation page.

Note that stakeholders from ICH Regions are encouraged to submit their comments to their respective Regulatory Authorities.