EMA – Publication of the Overview of comments received on ICH E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials
The draft ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials was subject to a public consultation between June and September 2025. The Overview of the comments received from the consultation are now available on the page dedicated to the guideline on the EMA Website.
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.
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vroby (11 décembre 2025). EMA – Publication of the Overview of comments received on ICH E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials. ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/15bv0





