EMA updates on safety monitoring of pediatric medicines

The European Medicines Agency has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the pediatric population.

It offers a holistic view of pediatric pharmacovigilance and provides guidance on how to make best use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. In addition it advises on how to adapt regulatory requirements to the pediatric population in the European Union.

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