WHO paediatric quality product profile assessment tool

Overview

This paediatric quality product profile assessment tool presents a framework for evaluating the age-appropriateness and suitability of paediatric formulations of medicines for use in patients aged 0 to ≤ 12 years. 

It may be used to evaluate currently available or existing formulations, including for example, those already included on essential medicines lists and paediatric formularies, as well as paediatric formulations under development. It may also be used to facilitate the identification of paediatric product formulation gaps, as well as formulations that may be unsuitable for use in children aged 0 to ≤ 12 years.

The tool should be used in applications for the inclusion of formulations of medicines for children on the WHO Model List of Essential Medicines for Children (EMLc).