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ProjTitle.icon P.II.B.3. Periodic safety update reports (PSURs)

The requirements for PSURs are detailed in GVP Module VII. The evaluation of data in the PSUR may be one way of further characterizing risks of medicine use during pregnancy and breastfeeding. In addition, in line with the guidance in GVP Module VII the following applies: - 

•  The PSUR needs to include all the relevant safety information related to the exposure during pregnancy and breastfeeding from all available recourses including the spontaneous ICSRs of adverse pregnancy outcomes, or adverse reactions/outcomes in the child following exposure in utero or during breastfeeding. In addition, ICSRs published in the medical literature, ongoing or finalized post-authorization studies (PASS), and ongoing or finalized observational study, e.g. a pregnancy registry, during the reporting interval. 

•  Age- and sex-specific drug utilization data need to be included (in PSUR section ‘Estimated exposure and use patterns’), which allows for an understanding of the extent to which the product is being used in women of childbearing age and pregnant or breastfeeding women. Available information regarding cumulative numbers of exposed patients and the method of exposure calculation should be provided. Sources of exposure data may include non-interventional studies, registries, and formal drug utilization studies in pregnant/breastfeeding women.

•  Safety during pregnancy and breastfeeding should also be described for products where adverse pregnancy outcomes or adverse events associated with breastfeeding is a safety concern (important risk or missing information) specified in the PSUR and/or the RMP, but it is encouraged also for products where these outcomes/events are not specified as a safety concern. This information on safety may come from dedicated, non-interventional studies, and in such cases, findings should be presented in PSUR section ‘Findings from non-interventional studies. Occurrence of spontaneous reports of adverse pregnancy outcomes should be presented in the PSUR section ‘Signal and risk evaluation’​

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