EMA – Open consultation on ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials
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.
The deadline of the consultation is 15 September 2025.
A dedicated page has been released by the EMA on its Website.
Find the templates to answer and more public consultations on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (28 juillet 2025). EMA – Open consultation on ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/14fyb





