Information to guide decision making for safe and effective use of medications during pregnancy and lactation is a large unmet need that hinders optimal care of women of childbearing potential. Pregnant women with serious illness may need medicines to maintain their health, to treat conditions that affect them during pregnancy to prevent irreversible damage and for healthy pregnancies. These patients, together with their healthcare professionals (HCPs), are invariably interested in better information on the risks that their disease and/or medication can pose to the foetus as well as to babies during breastfeeding. This topic addresses the unmet need for a science and data driven approach to define the standards for generating data on medicines used during pregnancy and breastfeeding. The resulting better and more complete scientific information on drug effects on pregnancy and lactation will be used to inform treatment decisions and will increase the quality of care for women.