FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Issues Updated Pediatric Pharmacovigilance Guidance

Nov. 16, 2018
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Updated European Medicines Agency guidelines on good pharmacovigilance practices for pediatric drugs are now in effect  — urging sponsors to pay particular attention to symptoms subjects may be unable to communicate.

Symptoms that depend on the patient’s ability to communicate them, such as nausea or changes in mood, may be under- or misreported in younger or mentally disabled children, the agency says.

Sponsors should report information on patient age in individual case safety reports (ICSRs) as accurately as possible in completed days for neonates, days or months for toddlers and infants, and completed years or months of children and adolescents. ICSRs should include as much information as possible about age at time of onset of reaction, including gestational age for neonates, pre-term neonates and infants.

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