Topic

ICSR reporting

Individual case safety reports (ICSRs) remain a core pharmacovigilance obligation. This topic collects updates on electronic reporting standards, gateway changes, and national expedited reporting expectations that affect PV operations and safety database teams.

2 matching updates · Sorted by impact priority

publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 11, 2026

TGA Approval 2026: Six Monthly Report Form for Unapproved Therapeutic Goods

Urgency: Low

Sponsors and MAHs must replace the 2021 form with the new 2026 approved form for all six-monthly reports on unapproved therapeutic goods supplied under SAS and CTA schemes.

Country ComplianceICSRRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Form

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publicFDA · USA · Updated Jun 4, 2026

FDA Final Guidance on Postapproval Requirements and Resources for ANDAs

Urgency: Low

Review the guidance to ensure compliance with post-marketing safety reporting timelines and annual report submissions; update SOPs for ICSR processing and periodic report generation.

Country ComplianceICSRRegulatory Intelligence Lead

SOP Impact3 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV

verifiedRegulatory action: Guideline

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