Harmonising regulatory approval for antibiotics in children

21 Jan, 2021

Authors: Phoebe C M Williams, John Bradley, Emmanuel Roilides, Linus Olson, Sheldon Kaplan, Irja Lutsar, Carlo Giaquinto, Daniel K Benjamin, Mike Sharland

Published in: The Lancet

Introduction: Antimicrobial resistance represents a substantial threat to the Sustainable Development Goals (SDGs), with a large impact on the health of children worldwide. However, very few paediatric trials for new antibiotics have been done to inform the optimal treatment of multidrug-resistant infections in children.

The current drug regulatory framework has evolved from a system that rightly aimed to protect children, yet remains governed by interpretation of laws established in response to historical incidents involving agents that caused harm. This approach, particularly for medicines from well established classes with a long experience of safe use in children (such as β-lactam penicillins), now unnecessarily complicates the process of paediatric antibiotic development, and is one of the many barriers to children with multidrug-resistant infections being appropriately treated with licensed drugs.