Jardim Claudia, Delgado-Charro M Begoña
Department of Life Sciences, University of Bath, Bath BA2 7AY, UK.
Pharmaceutics. 2025 May 10;17(5):635. doi: 10.3390/pharmaceutics17050635.
: Recent evidence supporting the medicinal use of cannabis has brought significant regulatory changes regarding its legal status, cultivation, and use. Several countries have adopted regulatory strategies enabling access to cannabis-based medicinal products; however, the regulation and availability of high-quality cannabis products differs globally. This work aimed to explore the regulatory pathways available for cannabis-based medicinal products, particularly those regulated as medicines, and establish the current landscape of those approved. : The public repositories of the European Medicines Agency, U.S. Food and Drug Administration, and Therapeutic Goods Administration were searched. A consumer website, Amazon, was searched to provide illustrative examples of cannabis products readily available to consumers. Finally, clinical trial data were collected to evaluate trends in medicinal cannabis research. : Only Epidyolex™ has been approved by these three agencies. Whilst topical cannabinoid consumer products are popular, no topical cannabis-based medicines have been approved by regulators, despite being the focus of several clinical trials. There are few regulator-approved cannabis-based medicines available and, evidence supporting the therapeutic use of consumer products is very limited. A complex regulatory and legislative scenario hinders research on and development of cannabis-based medicines, leaving a market gap filled with unregulated products that are potentially misleading regarding their therapeutic claims.
近期支持大麻药用的证据已使其在法律地位、种植和使用方面发生了重大监管变化。一些国家已采取监管策略，使基于大麻的药品能够得以获取；然而，高质量大麻产品的监管和可得性在全球范围内存在差异。这项工作旨在探索基于大麻的药品可用的监管途径，特别是那些作为药品进行监管的途径，并确立已获批准产品的当前情况。
对欧洲药品管理局、美国食品药品监督管理局和澳大利亚治疗用品管理局的公共数据库进行了检索。还对一个消费者网站亚马逊进行了搜索，以提供消费者容易获得的大麻产品的示例。最后，收集了临床试验数据，以评估药用大麻研究的趋势。
这三个机构仅批准了 Epidyolex™。虽然局部用大麻素消费品很受欢迎，但尽管有多项临床试验将其作为重点，但尚无基于大麻的局部用药品获得监管机构的批准。获批的基于大麻的药品很少，而且支持消费品治疗用途的证据非常有限。复杂的监管和立法情况阻碍了基于大麻的药品的研究和开发，导致市场出现空白，充斥着不受监管的产品，这些产品在治疗功效宣称方面可能具有误导性。
