EMA gives guidance on safety monitoring of medicines used in children

EMA has published the new good pharmacovigilance practice (GVP) chapter IV  on specific considerations for the paediatric population. It offers a holistic view of paediatric 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 paediatric population in the European Union.