The Regulatory Environment Surrounding Cannabis Medicines in the EU, the USA, and Australia
Claudia Jardim, M. Begoña Delgado-Charro
Abstract
Background/Objectives: 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. Methods: 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. Results: 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.