The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use

The efficacy and safety of medicines may be different in children compared to adults. The available documentation at the time of approval is, in general more sparse in children and long term data collection may be needed in order to clarify the safety profile in children and particularly to detect any long-term or delayed toxicities in the developing child. Therefore, there is a need to carefully consider how pharmacovigilance is conducted for medicines used by children and whether there are any aspects of the pharmacovigilance system that need to be enhanced to ensure adequate protection of public health. Furthermore, many medicines used to treat children are not licensed for such use (off-label use) or are not licensed at all (unlicensed use). This may further limit reporting of suspected adverse reactions to the pharmacovigilance systems.