Paediatric Investigation Plan [PIP]« Back to Glossary Index
« Back to Glossary Index
- Glossary: Market exclusivity
- Paediatric medicine: Challenges of early developmentPaediatric 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.
- Paediatric medicine: Regulations and other influencersThe regulations governing paediatric medicine differ between the EU and the US.
- Paediatric medicine: Paediatric Investigation PlanA 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.
- Marketing Authorisation ApplicationsThe 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.