4 June 2025
EMA: New guidelines on “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials”
The European Medicines Agency (EMA) has released a new guideline for public consultation. 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.
The guideline is jointly developed by global regulators and medicines developers through the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It highlights the need for the inclusion of people who can potentially give birth to children and ensure the safety of them, as well as their fetuses and babies.
The guideline is open for consultation until 15 September 2025.
For more information, see here.
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