Draft guideline on risk assessment of medicinal products in human reproduction and breastfeeding: from data to product information - Revision 1

🇪🇺 EMA · Mon 09 Nov 2026

EMA has published Revision 1 of its draft guideline on assessing the risks of medicinal products in human reproduction and breastfeeding, covering how nonclinical and clinical data are translated into product information. The input gives no detail on specific changes, but the guideline is relevant to how pregnancy, fertility and lactation information is written in SmPC and package leaflet sections, so labelling and PV teams should review the draft and consider whether to comment during consultation.

Official source: EMA ↗

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Draft guideline on risk assessment of medicinal products in human reproduction and breastfeeding: from data to product information - Revision 1

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