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Closed consultation

Consultation on the International Council for Harmonisation (ICH) E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials

Published 2025-07-03.

The MHRA is consulting with UK stakeholders to gather feedback and comments on a new international guideline for the appropriate inclusion and/or retention of pregnant and/or breast-feeding individuals in clinical trials of medicines.

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