Workshop: safe use of medicines during pregnancy and breastfeeding

8 July 2020

EMA is hosting a virtual workshop with its Patient and Consumers’ Working Party (PCWP) and Healthcare Professionals’ Working Party (HCPWP) on Tuesday 22 September to gather views from stakeholders on their experiences, concerns and expectations regarding the safe use of medicines by women who are pregnant or breastfeeding. These insights will inform the development and implementation of a strategy on medicine safety during pregnancy and breastfeeding.

An Agenda - Workshop on benefit-risk of medicines used during pregnancy and breastfeeding is available. 

The workshop will be broadcast and can be followed live via the ‘multimedia’ section on the event page on the day of the event. Participants will be asked their feedback and views on a range of issues around this topic using an interactive polling platform.

There will also be limited capacity to participate in a ‘virtual meeting room’. Participation in this virtual meeting room is subject to prior application. Available places at the workshop will be distributed to stakeholders depending on their EU-wide representation and/or expressed motivation to contribute to the discussion. To submit an expression of interest, please complete the online form by Monday, 17 August at 17:00 CET. 

In Europe, only a small number of medicines are authorised explicitly for use during pregnancy or breastfeeding. This is due to the limited information on the benefits and risks of the medicines to the mother and child, and how these should be balanced in this specific population. In addition, the optimal formulation and dosage of most medicines in this population is largely unknown due to a lack of research in this area.

However, more than half of all pregnant women use at least one medicine during their pregnancy and there are chronic conditions for which treatment is essential, including diabetes, epilepsy, and cardiovascular conditions. Other medicines may be needed to treat specific conditions that may develop during pregnancy, such as pre-eclampsia.

Therefore, EMA is developing a strategy for better research into the benefits and risks of medicines in pregnancy and breastfeeding. The aim of the strategy is to obtain evidence on medicines’ use and safety for pregnant and breastfeeding women and enable better decision-making on medical treatment for women who are planning to have a baby, who are pregnant or who wish to breastfeed their baby.

This initiative was proposed in EMA’s Regulatory science strategy to 2025 that was published earlier this year.