Module232025

12/05/2025

Comparison of Specific PSP and PIP - Template Structures

The Organisation for Professionals in Regulatory Affairs

9

M Dehlinger-Kremer, 14 May 2025

9

9

Comparison iPSP and PIP

Similar Content

Background on Disease Product Information

• • • • • • • • •

EU - PIP PDCO

USA - iPSP PeRC

Extrapolation Plan Formulation Plan Toxicology Plan

Clinical Plan

Waivers/Deferrals

Other Agency Agreements

Timelines

Key Differences

Timing

• •

Required Detail

• Waiver/deferral decision at time of product approval (US) • Key Binding Elements (EU) • Compliance Checks (EU)

The Organisation for Professionals in Regulatory Affairs

10

M Dehlinger-Kremer, 14 May 2025

10

10