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TGA

publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 5, 2026

TGA Consultation on Radiopharmaceutical Regulation in Australia

Review the consultation document and consider submitting feedback by 2026-07-31. Monitor for final regulatory changes affecting radiopharmaceutical safety monitoring and compliance.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Consultation

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publicTga · Australia · Updated May 24, 2026

Australia: TGA refreshes device post-market monitoring hub and responsibilities

Monitoring

1) Add/confirm the TGA 'medical device post-market monitoring and safety updates' page as a tracked regulatory intelligence source for routine review. 2) Cross-check internal Australia device vigilance SOPs/work instructions against TGA guidance on sponsor/manufacturer post-market responsibilities and document any gaps for CAPA/change control as needed.

Signal ValidationLocal Affiliate ComplianceLocal Safety Officer

SOP Impact5 SOPs

ConfidenceMedium

Relevant for: Local Safety Officer, Signal Management Lead, Regulatory Intelligence Lead

verifiedRegulatory action: Devices

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