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“headline”: “SOP for Paediatric Investigation Plan (PIP) Obligations Tracking”,
“description”: “This SOP defines procedures for managing and tracking Paediatric Investigation Plan (PIP) obligations in compliance with EMA requirements. It covers PIP preparation, submission, modifications, deferrals, waivers, and regulatory reporting obligations for sponsors and CROs.”,
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Standard Operating Procedure for Paediatric Investigation Plan (PIP) Obligations Tracking

Purpose

The purpose of this SOP is to establish a standardized process for managing Paediatric Investigation Plan (PIP) obligations as mandated under the European Paediatric Regulation (EC No 1901/2006). This ensures that sponsors comply with EMA requirements for the development and authorization of medicines intended for use in children, including deferrals and waivers.

Scope

This SOP applies to sponsors, CROs, regulatory affairs, clinical development, and QA personnel responsible for paediatric clinical development in the EU. It covers PIP submission, tracking obligations, reporting modifications, monitoring deferrals/waivers, and ensuring readiness for EMA inspections.

Responsibilities

• Sponsor: Prepares, submits, and tracks PIP obligations with EMA and ensures timely reporting.
• Regulatory Affairs: Manages PIP correspondence, submissions, and modifications in CTIS.
• CRO: Supports operationalization of PIP trials and assists with reporting.
• Clinical Development: Aligns trial design with approved PIP requirements.
• QA: Audits PIP compliance and ensures inspection readiness.

Accountability

The Sponsor’s Regulatory Affairs Lead is accountable for PIP compliance and timely fulfilment of obligations.

Procedure

1. PIP Preparation and Submission
1.1 Draft PIP in accordance with EMA requirements.
1.2 Submit via EMA’s Paediatric Committee (PDCO) portal.
1.3 Record submission in PIP Submission Log (Annexure-1).

2. Deferrals and Waivers
2.1 Identify if waiver or deferral applies.
2.2 Obtain formal approval from EMA.
2.3 Record in Waiver/Deferral Log (Annexure-2).

3. Modifications
3.1 Submit modifications for significant changes in study design or timelines.
3.2 Track approvals in PIP Modification Log (Annexure-3).

4. Tracking Obligations
4.1 Monitor timelines for PIP-related milestones.
4.2 Use internal tracking tools for trial execution.
4.3 Record updates in PIP Tracking Log (Annexure-4).

5. Results Reporting
5.1 Submit paediatric study results within required timelines.
5.2 Document in PIP Results Log (Annexure-5).

6. Inspection Readiness
6.1 Maintain inspection-ready records for PIP compliance.
6.2 Archive documentation in TMF.
6.3 Record in PIP Archiving Log (Annexure-6).

Abbreviations

• SOP: Standard Operating Procedure
• PIP: Paediatric Investigation Plan
• EMA: European Medicines Agency
• PDCO: Paediatric Committee
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• CTIS: Clinical Trials Information System

Documents

1. PIP Submission Log (Annexure-1)
2. Waiver/Deferral Log (Annexure-2)
3. PIP Modification Log (Annexure-3)
4. PIP Tracking Log (Annexure-4)
5. PIP Results Log (Annexure-5)
6. PIP Archiving Log (Annexure-6)

References

• EMA – Paediatric Investigation Plans
• Regulation (EC) No 1901/2006 on Medicinal Products for Paediatric Use
• ICH GCP Ethical Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: PIP Submission Log

Annexure-2: Waiver/Deferral Log

Annexure-3: PIP Modification Log

Annexure-4: PIP Tracking Log

Annexure-5: PIP Results Log

Annexure-6: PIP Archiving Log

Revision History

For more SOPs visit: Pharma SOP