SWOT analysis was used to gain insights and perspectives into the revision of the ICH S5(R2)
guideline on detection of toxicity to reproduction for medicinal products. The current ICH
guideline was rapidly adopted worldwide and has an excellent safety record for more than 20 years. The revised
guideline should aim to further improve reproductive and developmental (DART) safety testing for new drugs. Alternative methods to animal experiments should be used whenever possible. Modern technology should be used to obtain high quality data from fewer animals. Additions to the
guideline should include considerations on the following: limit dose setting, maternal toxicity, biopharmaceuticals, vaccines, testing strategies by indication, developmental immunotoxicity, and male-mediated developmental toxicity. Emerging issues, such as epigenetics and the microbiome, will most likely pose challenges to DART testing in the future. It is hoped that the new
guideline will be adopted even outside the ICH regions.