The European Medicines Agency (EMA) has published a new draft guideline offering key recommendations for the inclusion and retention of pregnant and breastfeeding individuals in clinical trials. This initiative aims to support the generation of robust clinical data in these populations, enabling more informed, evidence-based treatment decisions.
Developed through the International Council for Harmonisation (ICH), this guideline underscores that the participation of pregnant and breastfeeding people should be considered for all relevant medicinal products, shifting the common practice towards a new paradigm in clinical research. Currently, fewer than 0.4% of EU-submitted trials include pregnant individuals, and only 0.1% include those who are breastfeeding (CTIS data). This lack of inclusion often results in insufficient information in product leaflets, forcing healthcare providers and patients to make critical decisions without adequate evidence.
Based on these considerations, this document aims to set out clear scientific, regulatory, and ethical principles to protect both trial participants and their offspring and to close a long-standing evidence gap in clinical research.
The draft guideline is open for public consultation until 15 September 2025. Feedback can be submitted via the official EMA consultation template.