title: Medicine safety in pregnancy and ambitions for the EU medicine regulatory framework.
abstract: Is the European Union (EU) regulatory framework concerning pregnant women and women at risk of becoming pregnant fit for the purpose? This article discusses improvements in how medicines should be developed and monitored for safe and effective use by pregnant women and women at risk of becoming pregnant.
authors.affiliation: European Medicines Agency, London, UK.
authors.forename: A
authors.initials: A
authors.lastname: Saint-Raymond
authors.affiliation: European Medicines Agency, London, UK.
authors.forename: C S
authors.initials: CS
authors.lastname: de Vries
mesh_terms: D015195:Drug Design; D004335:Drug and Narcotic Control; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D005062:European Union; D005260:Female; D006801:Humans; D011247:Pregnancy; D012306:Risk