Topic

PV in clinical trials

Pharmacovigilance in clinical trials spans expedited SUSAR reporting, investigator safety communications, and development safety update reports (DSURs). This hub gathers trial-safety regulatory intelligence so PV and clinical safety leads can update SOPs before guidance becomes binding practice.

1 matching update · 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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