Abstract

Psychedelic therapies are making a comeback, with rapid increases in research programs, financial investment, and public interest. With likely regulatory approvals on the near horizon, interest is turning to the knowing-doing gap. Situations of ‘early access’ provide a window into the future, and an opportunity to better prepare globally. In 2023, the Australian drug regulator down-scheduled MDMA and psilocybin for certain conditions, establishing a world-first context for service delivery. This talk will highlight a set of key challenges and prospects within the unique Australian situation, alongside a set of recommendations for moving from research trials to clinics with relevance to regulatory approval globally.