Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - Scientific guideline

This document proposes the development of an addendum to the Guideline on the evaluation of medicines indicated for treatment of bacterial infections CPMP/EWP/558/95 rev 2), to provide specific guidance on paediatric clinical development programmes to support the authorisation of antibacterial agents for treating infectious diseases in children.

This concept paper proposes the development of an addendum to the guideline on the evaluation of new anti-bacterial medicinal products (CPMP/EWP/558/95 Rev. 2) to address the clinical development of antibacterial medicinal products for use in the paediatric population.