Therapeutic Goods Administration (TGA)

Manufacturers must evaluate their products against the new thresholds and update their risk management plans (RMPs) and risk-based monitoring protocols if any exceed the limits.

Regulatory teams must prepare for and implement processes for increased public disclosures and reporting obligations regarding medical device safety data in Australia.

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.

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.

Manufacturers must generate and maintain scientific, engineering, and clinical evidence demonstrating that their devices meet the Essential Principles for Safety and Performance.

Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.

Stop using affected batches; return to place of purchase for full refund.

Stop using and dispose of Pharmatech MK-677 capsules immediately; consult a healthcare professional if concerned.

Return recalled products to place of purchase for refund or contact Customer Care for return arrangements.

Ensure all patient implant cards are updated to include full UDI information in the mandated formats by the specified timeline to comply with TGA regulations.

Stakeholders are encouraged to utilize the provided e-learning modules to improve their inspection readiness and compliance with GCP standards in Australia.

Sponsors must align their products with the updated safety and formulation requirements for permissible ingredients as per the new determination.

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.

Sponsors must prepare for increased costs tied to the submission and maintenance of products on the ARTG which will impact their regulatory budget planning and compliance processes.

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

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