Freedom of information Decision for Psilocybin and MDMA Special Access-B Approvals in Australia from 2018 to 2022

This document is the <b>official notice of decision</b> from the <b>Therapeutic Goods Administration (TGA), Australian Government Department of Health and Aged Care</b>, regarding <b>Freedom of Information (FOI) request 4104</b>. The FOI request provides <b>historical regulatory data</b> on all <b>Special Access Scheme-B (SAS-B) applications</b> for <b>Psilocybin and MDMA</b> submitted between <b>January 1, 2018, and November 21, 2022</b>.The document details:The <b>number of applications lodged</b> under SAS-B for psilocybin and MDMA.The <b>outcomes of these applications</b>, including approvals, rejections, and pending cases.The <b>regulatory context</b> in which these applications were assessed.This FOI release is a <b>significant regulatory record</b>, offering <b>transparency into the TGA’s decision-making process</b> for psychedelic substances before their rescheduling in <b>July 2023</b>. It serves as a <b>key administrative law document</b> in understanding the evolution of psychedelic access in Australia and was one of the <b>main legal bases cited in the rescheduling process.</b>This dataset is a valuable resource for <b>researchers, policymakers, and legal professionals</b> examining the development of psychedelic medicine regulation in Australia.