This addendum to the Guideline on the evaluation of medicinal products 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.
For antibacterial agents with suitable spectra of activity, an extrapolation of efficacy from adults and/or from an alternative source population (i.e. from any one or more of adults, adolescents or children above a certain age) to a target paediatric population below a certain age is possible based on similar pathophysiology of the infectious disease across the target age groups. This situation applies to the majority of infectious diseases that occur in all or in a wide range of age subgroups. An extrapolation concept needs to be developed and detailed in an extrapolation plan…
