Module232025

07/05/2025

Pregnancy

The Organisation for Professionals in Regulatory Affairs

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Pregnancy Constituencies

1. Clinical trials intentionally conducted in pregnant subjects Fewer than 20 drugs for neither obstetric nor gynaecological are labelled for use in pregnancy. ICH E-21, currently in development, will provide guidance for the evaluation of IMPs in this population. 2. Incidental pregnancy during trial participation 40-50% of trial participants are women, many of child-bearing potential, so incidental pregnancies are almost inevitable.. 2. The pregnant partner Certain drugs, when administered to male animals, can express teratogenic and foetotoxic effects following mating with untreated females. Protocols increasingly recognised this as a possibility in humans

Although the first trimester is a time of particular sensitivity to teratogenic effects, many agents express these effects in later trimesters.

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