This presentation summarizes original research conducted by a HESI working group that looked at evaluation of fertility parameters in NHP for compounds approved in the US and EU between 2011-2022. Observations regarding historical use of NHP for fertility assessment will be presented, with a specific focus on age and sexual maturity. In addition, reporting of effects on fertility parameters in NHP in FDA and EU labelling will be discussed. The value of fertility assessment in NHP will be challenged and alternatives will be discussed.
