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.
Paediatric Committee (PDCO)
This article explores patient involvement in scientific regulatory committees in the EU, specifically in the activities of the European Medicines Association (EMA).
The regulations governing paediatric medicine differ between the EU and the US.