{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T04:18:06Z","timestamp":1791433086114,"version":"4.3.3"},"reference-count":33,"publisher":"Wiley","issue":"14","license":[{"start":{"date-parts":[[2024,12,19]],"date-time":"2024-12-19T00:00:00Z","timestamp":1734566400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,12,19]],"date-time":"2024-12-19T00:00:00Z","timestamp":1734566400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["British J Pharmacology"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:label\/>\n                    <jats:p>The past decade has seen a huge increase in clinical research with psychedelic drugs and 3,4\u2010methylenedioxymethamphetamine (MDMA), which have revealed great potential for treating mental health conditions. Given this progress in research, as well as the current unmet clinical need of millions of patients, in 2023, the Australian Therapeutic Goods Administration (TGA) approved the use of psilocybin for treatment\u2010resistant depression and MDMA for PTSD to take effect from 1 July 2023. The campaign for TGA approval was led by a coalition comprising the Australian charity Mind Medicine Australia with support from Professor David Nutt, Drug Science, Professor Arthur Christopolous, Professor Chris Langmead (both from Monash University) and from large numbers of clinical, academic and patient groups. Under the rescheduling, current prescribing rights are limited to psychiatrists who have become authorised prescribers under the TGA's Authorised Prescriber Scheme, and psilocybin can only be used for treatment resistant depression and MDMA can only be used for PTSD. This paper reviews the background for this decision, its implications for approvals in other jurisdictions, as well as for the development pathways for other psychedelic drugs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>LINKED ARTICLES<\/jats:title>\n                    <jats:p>\n                      This article is part of a themed issue Emerging Therapeutic Opportunities for Psychedelic and Related Drugs. To view the other articles in this section visit\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/bph.v183.14\/issuetoc\">http:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/bph.v183.14\/issuetoc<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bph.17398","type":"journal-article","created":{"date-parts":[[2024,12,19]],"date-time":"2024-12-19T18:58:14Z","timestamp":1734634694000},"page":"4048-4057","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["The Australia story: Current status and future challenges for the clinical applications of psychedelics"],"prefix":"10.1111","volume":"183","author":[{"given":"David J","family":"Nutt","sequence":"first","affiliation":[{"name":"Imperial College London and Drug Science  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Hunt","sequence":"additional","affiliation":[{"name":"Mind Medicine Australia  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2074-1917","authenticated-orcid":false,"given":"Anne Katrin","family":"Schlag","sequence":"additional","affiliation":[{"name":"Drug Science and Imperial College London  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Fitzgerald","sequence":"additional","affiliation":[{"name":"School of Medicine and Psychology Australian National University  Canberra ACT Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,12,19]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.16177"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/d41586-022-02873-8"},{"key":"e_1_2_11_4_1","unstructured":"BioSpace. (2023).Small pharma reports positive top\u2010line data from SPL026 (DMT)\u2010SSRI drug interaction study in patients with major depressive disorder. Small pharma reports positive top\u2010line data from SPL026 (DMT)\u2010SSRI drug interaction study in patients with major depressive disorder.https:\/\/www.biospace.com\/article\/small-pharma-reports-positive-top-line-data-from-spl026-dmt-ssri-drug-interaction-study-in-patients-with-major-depressive-disorder\/"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/0269881119841569"},{"key":"e_1_2_11_6_1","doi-asserted-by":"crossref","unstructured":"Bowen H.(2022 November 22).Suicide risk is high for military and emergency workers \u2013 but support for their families and peers is missing. The conversation.http:\/\/theconversation.com\/suicide-risk-is-high-for-military-and-emergency-workers-but-support-for-their-families-and-peers-is-missing-193451","DOI":"10.64628\/AA.x3ryxkydv"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1177\/02698811231182012"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/20503245231198472"},{"key":"e_1_2_11_9_1","unstructured":"Drug Science. (2021).Are psychedelics legal in the Netherlands? \u2010 Drug science. Are psychedelics legal in the Netherlands? \u2010 Drug science.https:\/\/www.drugscience.org.uk\/are-psychedelics-legal-in-the-netherlands\/"},{"key":"e_1_2_11_10_1","volume-title":"Data analysis and real world interrogation network (DARWIN EU) | European medicines agency","author":"European Medicines Agency (EMA)","year":"2023"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2206443"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopsych.2022.08.025"},{"key":"e_1_2_11_13_1","unstructured":"Hunt P.(2023).Draft clinical memorandum on the therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression.https:\/\/www.dropbox.com\/scl\/fi\/nx93rm0wr6tyae730a3na\/Nigel-Strauss-Letter_FINAL_220523.pdf?dl=0&e=1&rlkey=xz40fx95lzj2ph07trdisvquq"},{"key":"e_1_2_11_14_1","unstructured":"Mind Medicine Australia. (2022).Submission from the applicant opposing the interim decisions not to amend the poisons standard in relation to the restricted medical use of MDMA and psilocybine*.https:\/\/mindmedicineaustralia.org.au\/wp-content\/uploads\/Submission-TGA-Interim-Decisions_FINAL_241122.pdf"},{"key":"e_1_2_11_15_1","unstructured":"Mind Medicine Australia. (2023).Helping to change policy \u2013 Influencing the TGA with Professor David Nutt (UK).https:\/\/www.youtube.com\/watch?v=2qjFJecl7TU"},{"key":"e_1_2_11_16_1","unstructured":"Mind Medicine Australia. 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