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 addendum to the Guideline on the evaluation of medicines indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 3) has been developed to provide guidance on clinical development programmes that are required to support the authorisation of antibacterial agents for treatment of infectious diseases in paediatric patients.

Keywords: Antibacterial agents, paediatric population, paediatric bacterial infections, extrapolation of efficacy, paediatric study designs, timing paediatric studies

Current version

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

Adopted Reference Number: EMA/CHMP/187859/2017 Legal effective date: 01/12/2022

Document history

Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version

Draft: consultation closed Consultation dates: 06/04/2018 to 30/10/2018 Reference Number: EMA/CHMP/187859/2017 Summary:

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.

Draft concept paper on an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2) to address paediatric-specific clinical data requiremen...

Draft: consultation closed Consultation dates: 20/04/2016 to 31/07/2016 Reference Number: EMA/CHMP/213862/2016 Summary:

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.