ICH S5(R3) - Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals

What it says

S5(R3) provides guidance on testing for the detection of toxicity to reproduction and development of human pharmaceuticals. It describes study designs, species selection, timing of studies in development, and a weight-of-evidence approach to the assessment of risk, with attention to the use of alternative assays where appropriate.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Reproductive toxicity data determine whether women of childbearing potential can take part in trials and what precautions are needed.
• The timing of studies in the development program depends on the population and the risk.
• The overall assessment draws on all available information, not on a single study.

What inspectors look for

• Whether studies are suitable for the product and population.
• Whether conclusions are supported by the data.
• Whether labeling reflects the findings.

Related regulations