The European Medicines Agency has published a new module in its Good Pharmacovigilance Practices (GVP) series: Product- or population-specific considerations III, covering medicines used by pregnant and breastfeeding women, and children exposed in utero or via breastmilk. It has been in effect since 9 February 2026.
What’s changing
The central message is that safety data for these populations should be collected and evaluated systematically. The EMA asks marketing authorisation holders to follow up pregnancy and breastfeeding exposure cases in a structured way, to strengthen signal detection, and to plan pharmacovigilance activities proactively, even when no specific safety concern arose during the pre-authorisation phase.
What to do now
Pre-authorisation data on use in pregnancy and breastfeeding is almost always limited, so the post-authorisation phase is where the real-world picture is built. This is a good moment to revisit your special-situations procedures, from case intake and follow-up to signal management and periodic reporting, and to confirm they meet the new expectations.
How MPCA can help
Reviewing and updating special-situations procedures is familiar work for us. We can check your processes against the new guidance, support your signal and PSUR activities, and make sure the documentation holds up. Read more on our pharmacovigilance service page, and we are happy to talk it through for your products.
This article is for general information and reflects the situation at the time of writing. Always consult the EMA’s official publications for binding requirements.