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.
Recalling that it is good practice to systematically collect information on exposure to medicinal product during pregnancy the Guidance identifies specific situations in which assessing embryo-foetal effects following maternal exposure is of particular importance and may be considered in the Risk Management Plan:
Conditions and diseases requiring medicinal products for a medical need treatment;
Conditions and symptoms commonly treated during pregnancy;
Treatment with medicinal products belonging to classes of active substances with structural or mechanistic similarity;
Medicinal products representing a new class or a new mode of action if not already covered by the categories above.
The Guidance recommends that, as part of signal management, use of the EMA rule-based algorithm in EudraVigilance be considered by sponsors. This may permit more efficient retrieval of reported cases of suspected adverse reactions during pregnancy. The purpose of this approach is to reduce the burden of manually excluding irrelevant cases. The algorithm can be fine-tuned to align with the specific objectives of each organisation. A detailed description of the variables included in the EV pregnancy algorithm is provided in P.III. Appendix 2 to the Guidance.
The Guideline came into effect on 9 February 2026.