ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials – Scientific guideline

This International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline aims to provide recommendations for the appropriate inclusion of pregnant and breastfeeding individuals in clinical trials.

Many individuals who are pregnant or breastfeeding require medicine(s) to treat or prevent acute or chronic medical conditions. 

Robust evidence is needed to develop meaningful product labelling. This supports well-informed decision-making by pregnant and breastfeeding individuals and their healthcare professionals on such medicine use.

This ICH guideline has been introduced to provide recommendations for the appropriate inclusion of pregnant and breastfeeding individuals in clinical trials. It will facilitate the generation of clinical data that allow for evidence-based decision-making on the safe and effective use of medicinal products during pregnancy and breastfeeding.

Keywords: pregnancy, lactation, breastfeeding, clinical trials

Documents

ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials

Draft: consultation openConsultation dates: 04/06/2025 to 15/09/2025Reference Number: EMA/CHMP/ICH/149462/2025