Therapeutic Goods Administration (TGA)

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.