ICH E21: from landmark guidance to specific action for maternal and child health 

El Gaaloul M; Collaborative Group on Global Maternal and Child Health. Journal of Translational Medicine 2026,24(1):1000. doi:10.1186/s12967-026-08509-z

Summary: The International Council for Harmonisation (ICH) E21 draft guideline on the inclusion of pregnant and breastfeeding individuals in clinical trials marks a long-overdue step toward addressing persistent evidence gaps in maternal health. The authors of this letter to the editor explain that during public consultation, a coalition of ten organisations active in maternal and child health welcomed the draft but emphasised the need for clear, detailed guidance to ensure robust evidence is generated. They emphasize that pregnant and breastfeeding women must be protected through research, and that exclusion should only occur where robust scientific justification exists. They conclude that accelerating the operationalisation of ICH E21 is an opportunity to realise long-overdue progress in maternal and child health.

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