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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.
Note: Deferrals allow an applicant to delay development of the medicine in children until, for instance, there is enough information to demonstrate its effectiveness and safety in adults. Waivers are allowed when development of a medicine in children is not needed or is not appropriate, such as for diseases that only affect the adult population.
The PIP/PSP is not updated systematically, but a modification/amendment of an agreed PIP/PSP is possible (eg, if new information becomes available that has an impact on nature or timing of one of the key measures).
The Medical Writer can fulfill an important role in the document development process (eg, guide the team in providing the necessary information, write certain sections, ensure consistency in content across sections).