PharmacovigilanceOfficial

EMA issues revised draft guideline on reproduction and breastfeeding risk assessment

🇪🇺 EMA · Mon 09 Nov 2026

The agency has published Revision 1 of its draft guideline on assessing medicinal products' risks in human reproduction and breastfeeding, covering the path from data to product information.

The European Medicines Agency (EMA) published, on 9 November 2026, Revision 1 of its draft guideline on risk assessment of medicinal products in human reproduction and breastfeeding. The document is subtitled "from data to product information".

The full text was not available when this report was prepared, so the scope of the changes, the consultation timetable and the specific recommendations cannot be confirmed here. The title indicates that the guideline concerns how data on reproductive and breastfeeding risk are assessed and then reflected in product information.

As context, in the EU the statements on fertility, pregnancy and lactation normally appear in section 4.6 of the summary of product characteristics (SmPC). A draft guideline is not final, and its content may change after the agency has considered comments.

What it means for your team

  • Regulatory teams should read the full draft on the EMA website to see what has changed from the previous version and whether a consultation is open.
  • Teams responsible for product information and labelling should check whether the revision affects how pregnancy, fertility and lactation data feed into SmPC and package leaflet text.
  • Pharmacovigilance and safety scientists may wish to compare current reproductive-risk assessment practice with the draft once its detail is reviewed.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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