5 June 2025
Swissmedic: Launch of public consultation on “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials”
Swissmedic has launched the public consultation on Guideline E21 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Stakeholders in Switzerland can comment on the draft until 15 September 2025.
The guideline provides recommendations on how to include and retain pregnant and breastfeeding individuals in clinical trials. With this, it should be ensured that developers can generate robust clinical data in those populations in order that they and their healthcare providers can make informed, evidence-based decisions when using or prescribing medicines.
For more information, see here.
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