Updates on ISO 14155 and N=1 Therapeutics Discussed by TGA
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.
Primary source: Health Canada
Health Canada issued a recall for ARTIS Icono imaging systems due to potential safety or performance defects.
The defect may compromise patient or operator safety during imaging procedures.
Identify and quarantine affected ARTIS Icono systems in inventory; contact manufacturer for update guidance.
Regulatory Intelligence Lead
Single event
Contact the manufacturer or distributor for guidance on necessary software or hardware updates.
Identify and quarantine affected ARTIS Icono systems in inventory; contact manufacturer for update guidance.
Recall of ARTIS Icono Ceiling, Floor and Biplane Systems notified by Health Canada. The manufacturer or distributor should be contacted for guidance on necessary software or hardware updates.
What changed: Health Canada issued a recall for ARTIS Icono imaging systems due to potential safety or performance defects.
Why it matters: The defect may compromise patient or operator safety during imaging procedures.
Practical implication: Identify and quarantine affected ARTIS Icono systems in inventory; contact manufacturer for update guidance.
Published from the Firecrawl agent regulatory extraction pipeline.
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.
Safety lead to: (1) perform a UK-clinical-trial safety reporting gap assessment against MHRA’s effective guidance sections (MedDRA coding; AE/SAE; RSI governance; SUSARs; annual safety reporting; USMs; serious breaches; temporary suspension), (2) update controlled SOPs/WIs and training records to reflect “effective” status as of 28 Apr 2026, and (3) document deviations/gaps and open CAPA where needed for ongoing UK trials and new submissions.
Sponsors and MAHs must review and align safety data collection and reporting protocols with the newly adopted guidelines while preparing for implementation of PRAC recommendations stemming from this meeting.
Healthcare facilities must utilize the new checklist during inspections to conduct gap analyses and ensure compliance with reporting requirements associated with their vigilance systems.