‍HMA/EMA Guideline on good pharmacovigilance practice on pregnant and breastfeeding women and their children exposed in utero or via breastmilk

On 2 February 2026, the Heads of Medicines Agencies (HMA) together with the EMA, published a Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations III: Pregnant and breastfeeding women and their children exposed in utero or via breastmilk. The Guidance provides direction concerning the conduct of pharmacovigilance processes in relation to pregnant or breastfeeding women and children exposed in utero or via milk to medicinal products.