Therapeutic Goods Administration (TGA)

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.

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.