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.
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.
Small populations present ethical and practical challenges to organising clinical trials. Small populations include groups with rare diseases or specific sub-types of common diseases, children, and the elderly.