New guidance on safety monitoring of medicines in children

EMA has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population.

The new GVP chapter covers approved medicines with a paediatric indication or with an ongoing paediatric development, but also medicines only approved for adults when they are used off-label to treat children, i.e. for a medical purpose not in accordance with the terms of the marketing authorisation.