EMA helps ensure information is available on benefits and risks of medicine use during pregnancy and breastfeeding.
This use is common and includes people who are aware of their pregnancy as well as those who are not.
Healthcare professionals oversee the use of medicines for various conditions during pregnancy.
These conditions can be pregnancy-specific, worsened by pregnancy, or require continued medication during pregnancy. They include epilepsy, asthma, infections, diabetes, depression and auto-immune disorders.
For more information, see:
Up to 90 percent of people who are pregnant or breastfeeding take medication at some stage during these periods
40 percent of pregnant people report difficulty understanding what is available to them
71 percent of available medicines do not include information on use when pregnant
To find more statistics as those highlighted above, see:
EMA aims to enable access to solid evidence for patients and their healthcare providers on the benefits and risks of taking medicines during pregnancy and breastfeeding. This approach refers to both mother and child.
It includes improving the availability of evidence by identifying where the medicine lifecycle and current processes do not generate sufficient information. Where this is the case, EMA develops and implements regulatory and research changes to address the shortcomings.
EMA is running several initiatives that make use of opportunities in the medicine lifecycle, and that produce and communicate this evidence.
More information is available in the overview below as well as in the section on 'Research outcomes' on this page.
Preclinical
Clinical trials
Post-authorisation
Product communication
Select and expand the panels below to read more about EMA's research outcomes in relation to medicines during pregnancy and breastfeeding.
EMA conducted research into the value of pregnancy registries. This meant evaluating all registries identified since the early 2000s.
EMA published the results in 2018.
The findings feed into EMA's risk management strategy for medicines in pregnancy.
EMA joined the Innovative Medicines Initiative (IMI) in creating the Conception project in 2019.
Conception has established an infrastructure that can generate and disseminate evidence-based information on the effects of medicines used during pregnancy and breastfeeding. It does so in an efficient, systematic ethically responsible manner.
This infrastructure helps produce information on the impact of diseases and their treatments in pregnancy, as well as on medicine transfer into breast milk.
For more information, see:
EMA commissioned the Consign studies in 2020 to establish the impact of COVID-19 and its treatments on pregnancy and the unborn child.
This built on the Conception infrastructure (detailed in the expandable panel above).
EMA collaborated with academia and global regulators for these studies.
For more information, see:
EMA developed an algorithm in EudraVigilance to improve signal detection for adverse drug reactions during pregnancy.The Dutch adverse drug reaction center Lareb also currently uses the algorithm for pregnancy-specific signal detection.
The World Health Organization (WHO) adapted this algorithm to create their Vigibase global database.
For more information:
EMA commissioned a study to improve the information on antiepileptic medicineuse and on the feasibility of studying associated pregnancy outcomes.
If feasible, EMA aims to also commission a risk assessment study.
This initiative recognises the need for a more holistic approach to informed treatment choices forantiepileptic medicines in pregnancy.
For more information, see:
In July 2024, EMA finalised its evaluation of the added-value of PSURs (periodic safety update reports) and PSUSAs (periodic safety updates – single assessment) when it comes to generating pregnancy and breastfeeding-related information.
The aim is to use the results to inform guidance for industry and assessors.
EMA's findings and the resulting methodological guidance are reflected in:
In addition, EMA also ran a public consultation in 2024 for its guideline on risk assessment of medicines on human reproduction and lactation. This is in recognition that labelling should be improved.
Select and expand the panels below to read more about stakeholder engagement in relation to medicines during pregnancy and breastfeeding.
A guideline on inclusion of pregnant and breastfeeding individuals in clinical trials is available for public consultation.
The guideline provides recommendations on how to include and/or retain pregnant and breastfeeding people in clinical trials.
The goal is to ensure developers generate robust clinical data in those populations. This will help these individuals and their healthcare providers to make informed, evidence-based decisions when using medicines.
EMA and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) set up this guideline.
Submit your comments by 15 September 2025 via the dedicated template for submission of comments:
For more information, see:
EMA established a regulatory cluster on medicines in pregnancy and breastfeeding in 2021.
This cluster aims to achieve global alignment on the enhancement of benefit-risk information for medicines in pregnancy and breastfeeding. The approach is to do this via clinical trials, post authorisation safety studies, signal detection methods and labelling.
Alongside EMA, the cluster includes:
EMA hosted a stakeholder workshop on benefit-risk of medicines used during pregnancy and breastfeeding in 2020.
It highlighted the challenges for regulators, healthcare professionals, and patients.
For more information, see: