A new guideline recommending how to include or retain pregnant and breastfeeding people in clinical trials is open for public consultation.
The EMA’s ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials, seeks to ensure developers generate robust clinical data in these groups, to allow individuals and their healthcare providers to make informed, evidence-based decisions when using medicines.
It has been developed by global regulators and medicines developers through the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and marks a significant change in the development of medicines in pregnancy and breastfeeding.
Pregnant and breastfeeding people excluded from trials
Pregnant and breastfeeding people are currently often excluded from clinical trials, meaning product leaflets usually lack details about the benefits and risks of a medicine to their specific condition. This means patients and healthcare professionals are then left to make treatment decisions without this information.
It highlights that in principle, including pregnant and breastfeeding people in clinical trials should be considered for all medicines intended for people who can potentially give birth to children. It lays out the principles and conditions that should be met to ensure the safety of clinical trial participants, as well as their fetuses and babies.
“Pregnant and lactating individuals remain significantly underrepresented in clinical trials, resulting in critical gaps in knowledge around pharmacokinetics, safety, and efficacy during these dynamic physiological periods,” comments Women’s Brain Foundation CEO and Founder Dr Antonella Santuccione Chadha.
“To address this, we need regulatory reform and incentive-favouring inclusion, adaptive trial designs that accommodate pregnancy and breastfeeding, and structural support to enable participation.”
The EMA’s guideline outlines the scientific and regulatory principles, and ethical considerations, for the inclusion of pregnant and breastfeeding individuals in clinical trials. It is open for consultation until 15 September 2025, using this template and sent to [email protected].
