congenital anomaly

Formal Definition

Morphological, functional and/or biochemical developmental disturbance in the embryo or foetus whether detected at birth or not. The term congenital anomaly is broad and includes congenital abnormalities, foetopathies, genetic diseases with early onset, developmental delay. Both onset and diagnosis of congenital anomalies can be delayed.

HMA Guideline on good pharmacovigilance practices 2019
  • Categories: Pharmacokinetics, Pharmacovigilance