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Found 2 result(s) for "ISO 14155".

Showing 1-2 of 2 published article match(es)

publicTherapeutic Goods Administration (TGA) · Australia · Updated Aug 4, 2026

Recognition of ISO 14155:2026 in GCP Inspection Program

Immediate · High

Sponsors and investigators must develop an implementation plan for the ISO 14155:2026 standard and maintain records for review during TGA inspections, ensuring alignment with updated safety monitoring obligations.

Inspection ReadinessCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, PV Quality Lead, QPPV

verifiedRegulatory action: Notice

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publicTherapeutics Goods Administration · Australia · Updated Jul 20, 2026

Updates on ISO 14155 and N=1 Therapeutics Discussed by TGA

Immediate · High

Investigators need to modify trial protocols and safety reporting mechanisms in line with the latest ISO 14155 updates to ensure compliance for upcoming high-risk clinical trials.

Inspection ReadinessICSRRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, PV Quality Lead

verifiedRegulatory action: Notice

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