European Medicines Agency 7d ago

Up to 90% of women who are pregnant or breastfeeding use medicines, yet for many of these treatments, reliable safety data remains limited. Why does this gap exist—and how can it be addressed? In this episode of Inside EMA, Corinne de Vries, EMA lead on medicines in pregnancy and breastfeeding, explores the challenges of generating robust safety evidence for these populations. She explains how traditional approaches to clinical research have contributed to the lack of data and why it’s essential to rethink the inclusion of pregnant and breastfeeding individuals in clinical trials. Corinne also shares how regulators and researchers are working to generate better evidence throughout a medicine’s lifecycle. Strengthening this knowledge base is key to empowering mothers and healthcare professionals to make informed, confident decisions about treatment—supporting both maternal health and the wellbeing of their babies.