Swissmedic launches the public consultation on Guideline E21 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), with a deadline of 15 September 2025 for comments.
Public consultation on ICH Guideline E21 “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials” launched in Switzerland
05.06.2025
Stakeholders in Switzerland have until 15 September 2025 to comment on the draft of Guideline E21 “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials”.
This new ICH Efficacy guideline provides a globally harmonised framework and best practices to enable the appropriate inclusion and/or retention of pregnant and breast-feeding individuals in clinical trials (CTs) conducted to study product safety, efficacy, and dose/dosing regimens in these populations. The guideline addresses scientific and high-level regulatory principles such as the data required to define appropriate timing of inclusion and/or retention of pregnant and breast-feeding individuals or retention of individuals who become pregnant during CTs; the types of data to be collected and evaluated in CTs; planning how and when to include pregnant / breast-feeding individuals in CTs; situations in which the inclusion of pregnant / breast-feeding individuals in a CT is not recommended; ethical considerations.
The guideline will also provide practical guidance for planning CTs that include pregnant and/or breast-feeding individuals, e.g. protocol descriptions, informed consent, data collection considerations, parent and child follow-up (with reference to other ICH guidelines as ICH E6, E2A and E11).
Comments can be provided to networking@swissmedic.ch using the feedback form specified by ICH. Stakeholders will receive confirmation of receipt of their comments, but no feedback on the individual comments. After completion of the public consultation phase, the comments submitted will be discussed in the responsible ICH working groups and taken into account where appropriate.
Links to the guideline and feedback form can be found on the following page: