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.
Special considerations are necessary when prescribing medicines in special populations, such as children, the elderly, pregnant and breastfeeding women, and patients with renal (kidney) or hepatic (liver) impairment.
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.
Some groups within the general population of a clinical study may require special study, due to the particular risks, benefits, or treatment requirements associated with them