EMA Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

The European Medicines Agency (EMA) has introduced a draft new guideline on the inclusion of pregnant and breastfeeding women in clinical trials. The goal is to ensure that developers of clinical trials generate robust clinical data in relation to pregnant and breastfeeding women, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines.

Pregnant and breastfeeding women are often currently excluded from clinical trials, and those who become pregnant while participating in a clinical trial are often discontinued from the trial. Less than 0,4% of all clinical trials currently submitted in the EU include pregnant women. According to data from the Clinical Trials Information System (CTIS), this number falls to 0,1% regarding lactating mothers. As a result, product leaflets usually lack details about the specific benefits and risks of a medicinal product during pregnancy and breastfeeding, requiring patients and healthcare professionals to make treatment decisions without this essential information. This can lead to suboptimal treatment decisions and potential harm.

The guideline, developed jointly by global regulators and developers of medicinal products through the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), outlines the scientific and regulatory principles, as well as ethical considerations, on the basis of which pregnant and breastfeeding women may be included in clinical trials, both pre- and post-authorisation. It encourages proactive planning and early consultation by developers of medicinal products 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. Comments should be provided using this template and sent to ich@ema.europa.eu.