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.
Off-label use of a medicine is the use of an authorised medicine by a healthcare professional to treat a patient in a way not covered by the Marketing Authorisation (MA) and detailed in the Summary of Product Characteristics (SmPC) of the medicine.
Developing medicines for children is important, but requires special measures to be taken during clinical development in order to shield children from undue risk.
Special considerations must be taken into account in the development of paediatric medicine, including in terms of research and trial design and ethical concerns.
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.