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  • SMQ Pregnancy and neonatal topics was developed to replace original SMQ Adverse pregnancy outcome/reproductive toxicity (incl neonatal disorders) which had discrepancies in term inclusion resulting in maintenance issues. It was also developed to be more compatible with regulatory goals related to pregnancy and neonatal topics. Lactation associated disorders (functional and related to neonatal exposures through breast milk) are also in this SMQ, but fertility-related topics and developmental disorders are not. Referenced during construction of this SMQ was EMA\'s Guideline on the Exposure to Medicinal Products during Pregnancy: Need for Post-Authorisation Data in which pregnancy outcomes are defined as: Live birth, normal; Live birth, abnormal (including pre-term, term, and post-term birth; small for gestational age infants/ Intrauterine growth retardation; drug withdrawal syndrome in the neonate; malformations; and morbidity); Fetal death (including ectopic, miscarriage and stillbirth); and Termination of pregnancy. Sub-search SMQ Neonatal disorders relates to issues concerning the condition of the neonate including procedures to correct congenital disorders manifesting in the neonate.
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