Insights

The European Medicines Agency (EMA) has issued a new Good Pharmacovigilance Practices (GVP) Product‑ or Population‑Specific Considerations III on the use of medicines in pregnant and breast-feeding women, and children exposed in utero or via breast milk, in effect since February 9^th, 2026.

This guidance reinforces expectations for systematic monitoring, collection and evaluation of safety data in these populations, emphasizing structured follow‑up of pregnancy and breast-feeding exposure cases, stronger signal detection, and proactive planning of pharmacovigilance activities. Marketing Authorization Holders may need to implement additional pharmacovigilance measures.

Key changes at a glance:

• Assisted reproduction, obstetrics, pregnancy‑related conditions, maternal pre‑conception exposure are covered, while fertility products is out of scope
• Greater focus on pregnancy‑related physiological changes and need for pharmacokinetic (PK) studies in pregnancy or clinical lactation studies where appropriate
• Clear delineation of critical fetal development periods, need for organ‑specific analyses and long‑term child follow‑up, noting the inadequacy of analyzing all birth defects as a single category
• Explicit expectations for evaluating pregnancy and breast-feeding as missing information or as important (potential or identified) risks into Risk Management Plan (RMP)
• Strengthened PSUR requirements, including structured outcome reporting with timing of exposure, and integrated analyses when pregnancy/breast-feeding are safety concerns
• Risk‑proportionate triggers for Post-Authorisation Safety Studies (PASS), with preference for multi‑country real‑world data, feasibility assessments, and inclusion of breast-feeding exposure where feasible
• Recommendation to use the EudraVigilance rule‑based algorithm to more accurately identify pregnancy‑related cases

This update represents a significant step toward strengthening the protection of maternal and child health, while also promoting harmonization across the European Union.

RPN remains available to provide further updates on maternal exposure monitoring and to offer full support for any pharmacovigilance activities.