Paediatric Investigation Plan (PIP) / Paediatric Study Plan (PSP)

A pediatric investigation plan (PIP, required in the European Union) or pediatric study plan (PSP, required in the United States) is a development plan aimed at ensuring that the necessary data are obtained through clinical trials in the pediatric population. The purpose of the PIP/PSP is to give an overview of how clinical data will be obtained safely in trials involving children to support authorization of a medicine for them.

A PIP/PSP provides detailed background information about what is known about the disease in children and what treatment options are already available; describes the measures to be carried out in children with the medicine and the measures to adapt the medicine’s formulation to make its use more acceptable in children; how the studies will cover the needs of all age groups; and defines the timing of measures in children compared to adults.

All applications for marketing authorization for new medicines have to include the results of studies as described in an agreed PIP or PSP, unless the medicine is exempt because of a deferral or waiver. This requirement also applies when a marketing authorization holder wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already marketed.