S5 Reproductive Toxicology
S5(R3) Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals
This topic was endorsed by the ICH Steering Committee in March 2015 and the ICH S5(R3) Guideline on Detection of Toxicity to Reproductions for Human Pharmaceuticals reached Step 4 of the ICH Process in February 2020.
This third revision of the ICH S5 Guideline incorporates experience gained with the testing of pharmaceuticals using the current and novel testing paradigms as well as the advances of scientific, technological and regulatory knowledge over the past years. The ICH S5(R3) provides human safety assurance at least equivalent to that provided by current testing paradigms. In addition, this revision intends to provide greater clarity and alignment with other ICH Guidelines including ICH M3(R2), ICH S6(R1) as well as ICH S9.
Date of Step 4: 18 February 2020
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
S5(R4) Maintenance EWG S5(R3) Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals
In March 2019, the ICH Management Committee approved the establishment of a maintenance procedure for the S5 Guideline on on Detection of Toxicity to Reproductions for Human Pharmaceuticals. The maintenance procedure is available as part of the annexes of the Standard Operating Procedures for WGs. The annexes of ICH S5(R3) will be updated as new reference compounds, qualification approaches or new data become available.
*These Guidelines Belongs to ICH website.
