AMA submission on proposed changes to the Annual Charge Exemption Scheme Compliance Program

The AMA supports a robust, fair and transparent regulatory system for therapeutic goods, including appropriately funded post‑market monitoring and compliance functions that protect patient safety and sustain confidence in the Australian Register of Therapeutic Goods (ARTG).

The AMA encourages the regulator to implement the proposed powers alongside clear guidance, procedural fairness safeguards, and specific attention to evidence gaps arising from sponsorship transfers, while maintaining ongoing public disclosure of exemptions to support transparency and integrity.