Exploring the regulatory framework of psychedelics in the US & Europe

Exploring the regulatory framework of psychedelics in the US & Europe

Psychedelic drug therapy has gained prominence for its potential in treating various mental health conditions, including depression, post-traumatic stress disorder (PTSD), and anxiety. Psychedelic treatment differs from conventional psychiatric approaches in mode of action, legal status, and treatme...

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Published in:Asian journal of psychiatry Vol. 102; p. 104242
Main Authors: Behera, Hitesh Kumar, Joga, Ramesh, Yerram, Sravani, Karnati, Praveena, Mergu, Tejaswini, Gandhi, Kajal, M, Sowndharya, Nathiya, Deepak, Singh, Ravindra Pal, Srivastava, Saurabh, Kumar, Sandeep
Format: Journal Article
Language:English
Published: Netherlands Elsevier B.V 01-12-2024
Subjects:
DMT
Ketamine
Law
LSD
Magic mushrooms
MDMA
Mescaline
Policy
Psilocybin
Psychedelics
Regulatory
Magic mushrooms
Policy
Law
Ketamine
Regulatory
DMT
Psychedelics
Psilocybin
LSD
MDMA
Mescaline
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Summary:Psychedelic drug therapy has gained prominence for its potential in treating various mental health conditions, including depression, post-traumatic stress disorder (PTSD), and anxiety. Psychedelic treatment differs from conventional psychiatric approaches in mode of action, legal status, and treatment approach. This work delves into the therapeutic potential, mechanisms, and regulatory approvals of key psychedelic substances like psilocybin, 3,4-Methyl enedioxy methamphetamine (MDMA), mescaline, ketamine, and Lysergic acid diethylamide (LSD). It also provides an overview of legal aspects, and regulations surrounding psychedelics in the US & Europe, emphasizing their Schedule I classification due to potential misuse. The United States Food & Drug Administration (USFDA) closely monitors psychedelics, employing expedited pathways for evaluation. Further, recent guidance from the FDA on considerations for clinical Investigations supports the safe development of psychedelics for human welfare. European Medicines Agency (EMA) regulators focus on atypical psychedelics, addressing challenges in safety and efficacy. Marketed products, such as Spravato nasal spray, face limited distribution due to safety concerns. The call for careful regulation and legislation is essential for harnessing psychedelics' potential for therapeutic benefits and human welfare.
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ISSN:1876-2018
1876-2026
1876-2026
DOI:10.1016/j.ajp.2024.104242