EMA consultation – guideline for including pregnant and breastfeeding individuals in clinical trials

The European Medicines Agency (EMA) has opened a public consultation on a new guideline providing recommendations for including and retaining pregnant and breastfeeding people in clinical trials.

Many individuals who are pregnant or breastfeeding need medicine to treat or prevent medical conditions. However, pregnant and breastfeeding individuals are often excluded from clinical trials. If someone becomes pregnant during a trial, they are often required to stop taking part.

As a result, medicine leaflets usually lack detail about the benefits and risks of a medicine specifically in pregnancy and breastfeeding. This means that patients and healthcare professionals must make treatment decisions without this essential information.

The new guideline aims to help developers of new medicines collect robust and reliable data about how medicines work in people who are pregnant or breastfeeding. This will support informed, evidence-based decisions when using medicines.

Key points in the guideline

The key points from the guideline include:

• Considerations for including pregnant and breastfeeding people in clinical trials for all relevant medicines
• Scientific, regulatory, and ethical principles to ensure the safety of participants and their fetuses or babies
• Recommendations for early planning and proactive engagement between medicine developers and regulatory authorities to ensure the safety and efficacy of treatments during pregnancy and breastfeeding

How to take part in the consultation

Patients and healthcare professionals are invited to share their views.

Visit the EMA website for more information and to take part in the consultation.

The deadline for submission is 15 September 2025.