Exploring the regulatory framework of psychedelics in the US & Europe

IF 3.8 4区医学 Q1 PSYCHIATRY

Asian journal of psychiatry Pub Date : 2024-09-17 DOI:10.1016/j.ajp.2024.104242

Hitesh Kumar Behera , Ramesh Joga , Sravani Yerram , Praveena Karnati , Tejaswini Mergu , Kajal Gandhi , Sowndharya M , Deepak Nathiya , Ravindra Pal Singh , Saurabh Srivastava , Sandeep Kumar

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引用次数: 0

Abstract

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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探索美国和欧洲的迷幻剂监管框架

迷幻药物疗法因其在治疗抑郁症、创伤后应激障碍（PTSD）和焦虑症等各种精神疾病方面的潜力而备受瞩目。迷幻治疗在作用方式、法律地位和治疗方法上都有别于传统的精神病治疗方法。本著作深入探讨了主要迷幻药物的治疗潜力、机制和监管批准情况，如迷幻素、3,4-甲基二氧甲基苯丙胺（MDMA）、麦司卡林、氯胺酮和麦角酰二乙胺（LSD）。报告还概述了美国和欧洲有关迷幻药的法律和法规，强调了迷幻药因可能被滥用而被列入附表 I 的情况。美国食品和药物管理局（USFDA）密切监控迷幻剂，并采用快速评估途径。此外，美国食品和药物管理局最近发布的临床研究注意事项指南也支持为人类福祉安全开发迷幻剂。欧洲药品管理局（EMA）的监管机构重点关注非典型迷幻药，应对安全性和有效性方面的挑战。市场上销售的产品，如 Spravato 鼻用喷雾剂，由于安全问题，销售受到限制。呼吁谨慎监管和立法对于利用迷幻剂的潜在治疗功效和人类福祉至关重要。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Asian journal of psychiatry Medicine-Psychiatry and Mental Health

CiteScore

12.70

自引率

5.30%

发文量

297

审稿时长

35 days

期刊介绍： The Asian Journal of Psychiatry serves as a comprehensive resource for psychiatrists, mental health clinicians, neurologists, physicians, mental health students, and policymakers. Its goal is to facilitate the exchange of research findings and clinical practices between Asia and the global community. The journal focuses on psychiatric research relevant to Asia, covering preclinical, clinical, service system, and policy development topics. It also highlights the socio-cultural diversity of the region in relation to mental health.