Paediatric Investigation Plan [PIP]

Paediatric medicine development requires careful planning and decision making. Legislation in the EU mandates that paediatric medicine development should occur early in the medicine development process.

The regulations governing paediatric medicine differ between the EU and the US.

A Paediatric Investigation Plan (PIP) must be submitted in order to support a medicine's authorisation for use in children. The PIP undergoes a review process and ensures that paediatric development happens at the right time in the medicines development process. In special cases, the PIP can be waived.

The medicines development process' ultimate goal is an approval for marketing the new medicinal product – a Marketing Authorisation. This should be an integral part of all steps throughout the life-cycle of the medicinal product. A Marketing Authorisation Application contains information on quality, and non-clinical and clinical studies.