Concept addendum bij de richtlijn over evaluatie geneesmiddelen – geïndiceerd voor behandeling bacteriële infecties

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The European Medicines Agency has released for public consultation a 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.

This addendum to the Guideline has been developed to provide specific guidance on paediatric clinical development programmes that are required to support the authorisation of antibacterial agents for treatment of infectious diseases in paediatric patients. This Addendum provides guidance on clinical data requirements to support the approval of an antibacterial agent to treat infectious diseases in paediatric patients, both when extrapolation of efficacy from adults (source population) to paediatric patients (target population) is possible, and when this is not the case.

The draft guideline is available by clicking here.

Comments should be provided using this template and sent to by 30/08/2018.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

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