Pediatric Investigation/Study Plan (PIP/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 studies in children, to support the authorization of a medicine for children. 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 authorized and covered by intellectual property rights.

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