5.3.6 — Post-Marketing Experience

Reports of post-marketing clinical experience if drug marketed in other regions

Requirements by Phase

NDA: if_available

Content Requirements

• Reports of post-marketing clinical experience if available
• Periodic safety update reports (PSURs)
• Post-marketing surveillance data
• Signal detection and evaluation

Expected Deliverables

• Post-marketing experience report
• PSUR(s) if available

ICH Guidelines: E2C(R2), M4E(R2)

Source: ICH M4E