The European Medicines Agency (EMA) invites public feedback on a new draft guideline focused on including pregnant and breastfeeding populations in clinical trials, addressing critical gaps in medicine safety and efficacy data. The consultation is open until 15 September 2025.
On 4 June 2025, EMA published a draft guideline for public consultation that provides clear recommendations on how to include and/or retain pregnant and breastfeeding individuals in clinical trials. The objective of this guideline is to ensure that robust clinical data are generated to support informed, evidence-based decisions for these populations and their healthcare providers.
ObjectiveThe objective of this guideline is to generate robust clinical data ensuring safe and effective medicine use for pregnant and breastfeeding populations and evidence-based decisions for these populations and their healthcare providers.
Significance- This new guideline represents an important paradigm shift in the development of medicines for use during pregnancy and breastfeeding.
- Developed jointly by global regulators and industry through the International Council for Harmonisation (ICH).
- It establishes key scientific, regulatory, and ethical principles, as well as the conditions required to ensure the safety of clinical trial participants, their fetuses, and infants.
Pregnant and breastfeeding individuals are currently underrepresented in clinical trials.
- Less than 0.4% of trials submitted in the EU include pregnant individuals at enrollment or retain them if pregnancy occurs during the study.
- Only 0.1% of trials include breastfeeding individuals (Clinical Trials Information System [CTIS] data).
- Participants who become pregnant during a trial are often withdrawn, further limiting data availability.
- The guideline provides recommendations on planning, conducting, and reporting clinical trials involving pregnant and breastfeeding individuals.
- It addresses inclusion during both pre-authorization and post-authorization phases of medicine development.
- It promotes proactive planning and early dialogue between medicine developers and regulatory authorities.
- It sets out the scientific, regulatory, and ethical framework to safeguard the safety of pregnant and breastfeeding participants, their fetuses, and infants.
- It encourages the development of high-quality evidence to inform clinical care and regulatory decision-making.
- The draft guideline is now open for public consultation.
- Deadline for comments: 15 September 2025.
Comments must be provided using the official EMA template and sent to: ich@ema.europa.eu
ReferenceRead the EMA announcement: EMA news