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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:
In this podcast episode, Corinne de Vries, EMA's lead on medicines in pregnancy and breastfeeding, explains how better safety data on medicine use during pregnancy and breastfeeding can be generated across all stages of a medicine's lifecycle.
She also highlights key opportunities for change, including the need to rethink the inclusion of pregnant and breastfeeding people in clinical trials.
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
EMA conducted research into the value of pregnancy registries. This meant evaluating all registries identified since the early 2000s.
The findings feed into EMA's risk management strategy for medicines in pregnancy.
EMA developed an algorithm within EudraVigilance, the European system for collecting and analysing suspected side effects of medicines, to improve signal detection for adverse drug reactions during pregnancy.
The Dutch pharmacovigilance centre Lareb also uses the algorithm to support pregnancy-specific signal detection.
The World Health Organization (WHO) adapted the algorithm for use in VigiBase, its global database of suspected adverse drug reactions.
For more information:
Through DARWIN EU® (Data Analysis and Real World Interrogation Network), EMA commissions studies on disease patterns, disease burden and medicine use in pregnancy and breastfeeding.
These studies generate real world evidence to improve understanding of how medicines are used and perform in pregnancy and breastfeeding, particularly where limited information is available from clinical trials.
Information on individual studies is available in the HMA-EMA catalogues of real world data studies. Click on the expandable panel below to find the links to these studies.
EMA joined the Innovative Medicines Initiative (IMI) in launching the Conception project in 2019.
Conception generates and shares reliable information on the use and safety of medicines during pregnancy and breastfeeding.
It helps improve understanding of the effects of diseases and their treatments during pregnancy, as well as how medicines can pass into breast milk.
For more information, see:
EMA commissioned the Consign studies in 2020 to establish the impact of COVID-19 infection and its treatments on pregnancy and the unborn child.
These studies built on the existing Conception infrastructure (as described above) and were conducted in collaboration with academic partners and global regulators across the EU, USA, South America, Canada and Saudi Arabia.
For more information, see:
The guideline on the risk assessment of medicines on human reproduction and lactation is currently under revision. EMA consulted on a guideline in 2024.
The guideline aims to improve the information available in product information on the use of medicines during pregnancy and breastfeeding.
EMA is contributing to the development of the ICH E21 guideline on the inclusion of pregnant and breastfeeding individuals in clinical trials.
The guideline aims to support the generation of robust evidence in these populations and help inform treatment decisions.
The guideline was open for consultation between June and September 2025.
For more information, see:
A guideline is available on good pharmacovigilance practices (GVP) for the use of medicines in pregnant and breastfeeding individuals, and children exposed in utero or via breast milk.
It outlines expectations for monitoring and evaluating safety data in pregnancy and breastfeeding, including structured follow up, improved signal detection and proactive pharmacovigilance planning.
EMA published the guideline in February 2026.
It is available on EMA's webpage on GVP:
Select and expand the panels below to read more about stakeholder engagement in relation to medicines during pregnancy and breastfeeding.
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:
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in February 2026.
2 September 2026
Podcast episode and information on GVP guideline added; editorial updates throughout the page
6 February 2026
Summary of published findings from two Consign studies on the impact of COVID-19 on pregnancy added to the 'Research outcomes' section