Description
Pediatric Investigation Plan (PIP) Development – EMA Requirement
The Pediatric Investigation Plan is a mandatory requirement for marketing authorization applications in the European Union. A well-crafted PIP demonstrates your commitment to developing age-appropriate formulations and generating pediatric safety and efficacy data – or provides scientific justification for waivers and deferrals.
Editverse provides comprehensive PIP development services from initial strategy through EMA Pediatric Committee (PDCO) submission, opinion response, and post-approval compliance monitoring.
What is a Pediatric Investigation Plan?
The PIP is a development plan designed to ensure that necessary data are obtained through studies in children to support authorization of a medicine for pediatric use. Key elements include:
- Development Program – Clinical studies required in pediatric populations
- Formulation Development – Age-appropriate dosage forms
- ⏰ Timing and Milestones – When pediatric studies will be conducted
- Waivers and Deferrals – Scientific justification when pediatric development is not appropriate or should be delayed
Regulatory Framework
| Regulation/Guideline | Requirement |
|---|---|
| EC 1901/2006 | Pediatric Regulation – establishes PIP requirement and PDCO role |
| EC 1902/2006 | Amendment to Pediatric Regulation |
| ICH E11(R1) | Clinical Investigation of Medicinal Products in the Pediatric Population |
| EMA PIP Guidance | Format and content requirements for PIP applications |
| EMA PDCO Guidelines | Disease-specific and age-group guidance documents |
PIP Application Components
| Section | Content |
|---|---|
| Administrative Information | Applicant details, product identification, proposed indication |
| Condition and Target Population | Disease epidemiology, unmet pediatric need, age subsets |
| Available Data Summary | Existing nonclinical and clinical data relevant to pediatrics |
| Proposed Development Plan | PK/PD studies, efficacy studies, safety monitoring by age group |
| Formulation Development | Age-appropriate formulations, palatability, dosing flexibility |
| Timing and Milestones | Timeline for pediatric studies relative to adult development |
| Waiver/Deferral Requests | Scientific justification for any age groups/indications |
Service Options
| Service | Description | Timeline |
|---|---|---|
| Full PIP Development | Complete PIP application with clinical development plan | 8-12 weeks |
| Waiver Application | Full waiver request with scientific justification | 4-6 weeks |
| PIP Modification | Amendment to agreed PIP (study changes, timeline updates) | 4-6 weeks |
| PDCO Opinion Response | Response to PDCO questions and requests for information | 2-4 weeks |
| Compliance Report | Annual PIP compliance reporting for agreed plans | 2-3 weeks |
PIP Development Workflow
| Phase | Activities | Duration |
|---|---|---|
| 1. Strategy Development | Pediatric landscape analysis, PDCO precedent review, strategy alignment | Week 1-2 |
| 2. Data Compilation | Gather nonclinical, clinical, and CMC data relevant to pediatrics | Week 2-4 |
| 3. PIP Drafting | Write all PIP sections including proposed studies and justifications | Week 4-8 |
| 4. Internal Review | Pediatric expert and regulatory review | Week 8-9 |
| 5. Sponsor Review | Client review and alignment with development strategy | Week 9-11 |
| 6. Finalization | Final QC, EMA portal formatting, submission preparation | Week 11-12 |
Pediatric Age Groups Covered
| Age Group (ICH E11) | Age Range | Key Considerations |
|---|---|---|
| Preterm Neonates | <37 weeks gestational age | Organ immaturity, dosing challenges |
| Term Neonates | 0-27 days | Rapid developmental changes |
| Infants/Toddlers | 28 days to 23 months | Growth-related PK changes |
| Children | 2-11 years | Weight-based dosing, palatability |
| Adolescents | 12-17 years | Often similar to adults, puberty considerations |
Why Choose Editverse
| Feature | Benefit |
|---|---|
| PDCO Expertise | Writers experienced with PDCO expectations and common requests |
| Pediatric Development Knowledge | Understanding of age-appropriate study designs and endpoints |
| Waiver Strategy | Strong justifications for full or partial waivers when appropriate |
| Formulation Input | Guidance on age-appropriate formulation development |
| Post-Opinion Support | Response to PDCO questions and modification requests |
Deliverables
- Complete PIP Application – EMA format compliant
- Pediatric Development Plan – Detailed study proposals by age group
- Scientific Justification – For waivers, deferrals, or study design decisions
- Supporting Documentation – Literature review, disease background
- EMA Portal Submission Package – Ready for electronic submission
Get Started
Contact us to discuss your pediatric development strategy:
Email: co*****@*******se.com
Web: editverse.com
Pricing provided in your local currency. Combined packages available with other regulatory writing services.
