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.

1 matching update · Sorted by impact priority

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

Checklist for Prescribing Psychiatrists of MDMA and Psilocybine

Monitoring

Review and implement the TGA checklist for all psychiatrist prescribers of MDMA/psilocybine; update ICSR workflows to capture adverse events as per checklist requirements.

Country ComplianceICSRRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Checklist / Form

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