This topic was endorsed by the ICH Assembly in May 2022.

Further to the ICH Management Committee’s endorsement of the E21 Concept Paper in June 2023 the E21 Guideline seeks to provide a globally accepted framework and best practices to enable inclusion and/or retention of pregnant and breast-feeding individuals in clinical trials and will cover principles and practices to enable the collection of a sufficiently robust set of safety, efficacy, and/or pharmacokinetic data in pregnant and breast-feeding individuals which will better inform clinical decision-making in medicinal product use (e.g., improved product labelling). The guideline will establish a common understanding between regulatory authorities, industry, and other stakeholders and harmonise strategies and methodologies for enrollment and retention of pregnant and/or breast-feeding individuals into clinical trials and overall drug development plans.