EMA Publishes Guidance on Pediatric Drug Safety

EMA announced on Nov. 13, 2018 that it has published a new guideline that offers a holistic view of pediatric pharmacovigilance. The guideline discusses the use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. The guideline also provides information on how to adapt regulatory requirements to the pediatric population in the European Union.

The new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the pediatric population discusses off-label use and medication errors, risk management plans, periodic safety update reports, post-authorization safety studies, signal management, and safety communication. It also stresses the importance of comprehensive detailed information in adverse drug reaction reports.

The guideline applies to approved drugs with a pediatric indication or ongoing pediatric development. Medicines approved for adults that are also used off-label to treat children are also covered.

Source: EMA