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.本文件为澳大利亚卫生与老龄部（Australian Government Department of Health and Aged Care）下属治疗用品管理局（Therapeutic Goods Administration, TGA）发布的正式决策公告，涉及信息自由法（Freedom of Information, FOI）第4104号申请。该信息自由申请公开了2018年1月1日至2022年11月21日期间提交的所有针对裸盖菇素（Psilocybin）与亚甲二氧基甲基苯丙胺（MDMA）的特殊准入计划B（Special Access Scheme-B, SAS-B）申请的历史监管数据。文件详细涵盖以下内容：针对裸盖菇素与MDMA的SAS-B申请受理数量、此类申请的审批结果（包括获批、驳回及待处理案件），以及评估此类申请时的监管背景。本次信息自由公开文件属于重要监管档案，可揭示2023年7月裸盖菇素与MDMA重新分类前，TGA针对致幻物质的决策流程，提升监管透明度。该文件是理解澳大利亚致幻物质准入政策演变的核心行政法文件，同时也是此次重新分类程序中援引的主要法律依据之一。本数据集可为研究澳大利亚致幻药品监管发展的研究人员、政策制定者与法律从业者提供极具价值的研究资源。