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

This document is the official notice of decision from the Therapeutic Goods Administration (TGA), Australian Government Department of Health and Aged Care, regarding Freedom of Information (FOI) request 4104. The FOI request provides historical regulatory data on all Special Access Scheme-B (SAS-B) applications for Psilocybin and MDMA submitted between January 1, 2018, and November 21, 2022.

The document details:

• The number of applications lodged under SAS-B for psilocybin and MDMA.
• The outcomes of these applications, including approvals, rejections, and pending cases.
• The regulatory context in which these applications were assessed.

This FOI release is a significant regulatory record, offering transparency into the TGA’s decision-making process for psychedelic substances before their rescheduling in July 2023. It serves as a key administrative law document in understanding the evolution of psychedelic access in Australia and was one of the main legal bases cited in the rescheduling process.

This dataset is a valuable resource for researchers, policymakers, and legal professionals examining the development of psychedelic medicine regulation in Australia.