New EU guidelines on pregnancy and breastfeeding in clinical trials

The European Medicines Agency (EMA) has launched a consultation on guidelines on how to include and retain pregnant and breastfeeding women in clinical trials. The goal is to ensure developers generate robust clinical data in those populations, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines.

This guideline, developed jointly by global regulators and medicines developers marks a change in paradigm in the development of medicines in pregnancy and breastfeeding.

It highlights that in principle, including pregnant and breastfeeding participants in clinical trials should be considered for all medicines intended for people who can potentially give birth to children. It lays out the principles and conditions that should be met to ensure the safety of clinical trial participants, as well as their foetuses and babies.

Currently, women who are pregnant or breastfeeding are often excluded from clinical trials and those who become pregnant while participating in a clinical trial are frequently discontinued from the clinical trial. Less than 0.4% of all clinical trials currently submitted in the EU include pregnant people, and this falls to 0.1% regarding lactating individuals, according to data from the Clinical Trials Information System (CTIS).

As a result, product leaflets usually lack details about the benefits and risks of a medicine specifically in pregnancy and breastfeeding, requiring patients and healthcare professionals to make treatment decisions without this essential information. Meanwhile, the vast majority of pregnant people take medications, for example because of chronic diseases, infections, or pregnancy complications. The situation is similar in breastfeeding populations.

The guideline outlines the scientific and regulatory principles, as well as ethical considerations, for the inclusion of pregnant and breastfeeding individuals in clinical trials, both pre- and post-authorisation. It encourages proactive planning and early consultation of medicine developers with regulatory authorities to ensure the safety and efficacy of treatments during pregnancy and breastfeeding.

The guideline is open for consultation until 15 September 2025.