Bridging the gap between academic research and real-world solutions
In the pursuit of scientific advancement, the journey from theoretical research to tangible solutions is often fraught with challenges.
The European Medicines Agency (EMA) has released a draft guideline for public consultation that encourages the inclusion and retention of pregnant and breastfeeding individuals in clinical trials. Developed through the International Council for Harmonisation (ICH), the guideline aims to ensure robust clinical data is generated for these populations so they and their healthcare providers can make informed, evidence-based decisions when using medicines.
This marks a significant shift in the development of medicines intended for people who may become pregnant or are breastfeeding. The document states that, in principle, these populations should be considered for inclusion in all relevant trials. It provides clear scientific, ethical, and regulatory frameworks to ensure safety for participants, fetuses, and infants throughout the clinical trial process.
Currently, pregnant and breastfeeding individuals are largely excluded from trials, and those who become pregnant mid-trial are often removed. According to the Clinical Trials Information System (CTIS), fewer than 0.4% of EU clinical trials include pregnant participants, and only 0.1% involve breastfeeding individuals. As a result, product information leaflets often lack critical safety and efficacy data for these groups, forcing patients and healthcare professionals to make treatment decisions based on limited or no evidence.
This situation poses risks, particularly since most pregnant and breastfeeding people require medication—whether for chronic illnesses, infections, or pregnancy-related complications. The lack of specific data may lead to delayed, altered, or suboptimal treatment, affecting both maternal and child health.
The new guideline outlines the conditions under which pregnant and breastfeeding people may be ethically and scientifically included in clinical trials, covering both pre- and post-authorisation studies. It emphasizes the need for early dialogue between medicine developers and regulators to balance participant protection with the generation of essential data.
EMA encourages stakeholders to review the proposed guideline and submit comments by 15 September 2025. Feedback must be submitted via the provided template and sent to ich@ema.europa.eu. This initiative represents a step forward in closing a critical data gap and ensuring more equitable and evidence-based healthcare.
