Pediatric Investigation Plan(PIP)
The EU regulatory requirement for sponsors to submit a plan for pediatric development of a medicinal product to EMA's Paediatric Committee.
Usage Examples
- The PIP was agreed with PDCO including deferrals for children under 2 until additional safety data accumulated.
- A Class Waiver applied because the disease does not occur in the pediatric population.
- The US PSP aligned dosing rationale with the EU PIP to support coordinated pediatric development.
What is PIP?
A Pediatric Investigation Plan (PIP) is a development plan for a medicinal product in the pediatric population, required by the EU Paediatric Regulation (EC) No 1901/2006 as part of most EU marketing authorization applications. The PIP describes the studies the sponsor will conduct in children, including dosing, formulation development, and clinical trials, and covers all pediatric subsets from preterm newborns through adolescents unless a waiver is granted.
The Paediatric Committee (PDCO) at EMA reviews and decides on PIPs. Sponsors must submit a PIP at the end of Phase 1 adult studies (typically), and PDCO opinions are binding — the final MAA must reflect completion of the agreed PIP studies unless a deferral is granted. Non-compliance with the PIP can prevent MAA approval.
The US analog is the Pediatric Study Plan (PSP) required by the FDA Safety and Innovation Act (FDASIA) of 2012. Sponsors of new drugs and biologics filing NDAs or BLAs must submit a PSP, with review by FDA and agreement on pediatric studies. The US and EU approaches are aligned in intent but differ procedurally, and sponsors typically align content between PIPs and PSPs to support global pediatric development.
Regulatory Context
This term appears most often in submission & approval workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside REGULATION EC 1901 2006, FDASIA.
When This Matters
- The PIP was agreed with PDCO including deferrals for children under 2 until additional safety data accumulated.
- A Class Waiver applied because the disease does not occur in the pediatric population.
- The US PSP aligned dosing rationale with the EU PIP to support coordinated pediatric development.
Common Mistakes
- Treating submission readiness as a formatting-only check without lifecycle validation.
- Using outdated guidance references across modules and summaries.
- Missing cross-functional review between RA, CMC, and quality before submission.
Related Regulations
Frequently Asked Questions
A PIP must generally be submitted no later than the completion of pharmacokinetic studies in adults — typically end of Phase 1. Sponsors may file earlier to inform development strategy, but cannot wait until MAA submission. A PDCO opinion is required before the MAA will be accepted.
Yes. PDCO can grant a Product-Specific Waiver (for a specific product where pediatric use is clinically inappropriate or unlikely to provide therapeutic benefit) or apply a Class Waiver (for diseases that only affect adults). Partial waivers for specific age groups are also possible.
Non-compliance with an agreed PIP generally prevents MAA approval for the product — this is the key enforcement mechanism of the Paediatric Regulation. Sponsors can request modifications or deferrals during development, but PDCO must agree to changes. Completion of the PIP qualifies the product for an additional 6 months of supplementary protection certificate extension.
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