Rescheduling psilocybin and MDMA in Australia - A process explainer

There is a proposal before Australia's poisons, medicines and drug regulator, the TGA (Therapeutic Goods Administration) to down-schedule MDMA and psilocybin from Sch 9 to Sch 8, for use in limited therapeutic settings.

The TGA will be considering their position (once more) in December 2021, following the September 30th tabling of an independent report.

Nick Wallis from the Australian Psychedelic Society speaks with Dr. Stephen Bright from PRISM (Psychedelic Research In Science and Medicine), Dr. Samuel Douglas (APS President) and Simon Beck (APS) about the report, the proposal and the process.

TGA scheduling decisions are highly bureaucratic and often confusing, so let us help you break it down to something more understandable, so you know exactly what is and is not being proposed.

REFERENCES
1. Consultation: Proposed amendments to the Poisons Standard - ACMS, ACCS and Joint ACMS/ACCS meetings, November 2020
www.tga.gov.au/consultation-invitation/consultation-proposed-amendments-poisons-standard-acms-accs-and-joint-acmsaccs-meetings-november-2020

2. The Poisons Standard - Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
www.tga.gov.au/publication/poisons-standard-susmp

3. Know the ACT Cannabis rules - Effective 31 January 2020
www.act.gov.au/cannabis/home

4. PRISM’s Response: TGA Rescheduling of Psilocybin and MDMA Independent Expert Review Panel Report 1st October 2021
www.prism.org.au/prisms-response-tga-expertreview

5. AMA submission to the Therapeutic Goods Administration – proposed amendments to the Poisons Standard – November 2020
www.ama.com.au/articles/ama-submission-therapeutic-goods-administration-proposed-amendments-poisons-standard-0

6. Clinical Memorandum - Therapeutic use of psychedelic substances | May 2020
www.ranzcp.org/files/resources/college_statements/clinical_memoranda/cm-therapeutic-use-of-psychedelics.aspx

7. The Age - 'Missing middle' leaves too many Victorians without mental health support - Christopher Davey - 18th Aug 2020
www.theage.com.au/national/victoria/missing-middle-leaves-too-many-victorians-without-mental-health-support-20200817-p55mnh.html

SPECIAL THANKS:
Psychedelic Research In Science and Medicine - PRISM
prism.org.au