This page provides detailed guidance for companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver, as well as for companies that already have an agreed PIP.

HumanRegulatory and procedural guidancePaediatricsResearch and development

This page lists the templates and forms required by companies wishing to apply for a paediatric investigation plan (PIP), deferral or waiver. Deadlines for submitting applications to the Paediatric Committee (PDCO) are also available below.

HumanRegulatory and procedural guidancePaediatricsResearch and development

The European Medicines Agency (EMA) maintains a list of class waivers for medicines that are not required to submit a paediatric investigation plan (PIP) as part of a marketing authorisation application. These medicines are likely unsafe or ineffective in children, lack benefit for children or are for diseases and conditions that only affect the...

HumanRegulatory and procedural guidancePaediatricsResearch and development