The Regulatory Environment Surrounding Cannabis Medicines in the EU, the USA, and Australia
<b>Background/Objectives</b>: 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; h...
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MDPI AG
2025-05-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/17/5/635 |
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| author | Claudia Jardim M. Begoña Delgado-Charro |
| author_facet | Claudia Jardim M. Begoña Delgado-Charro |
| author_sort | Claudia Jardim |
| collection | DOAJ |
| description | <b>Background/Objectives</b>: 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. <b>Methods</b>: 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. <b>Results</b>: 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. |
| format | Article |
| id | doaj-art-a1ccf10d49e04e6fbbaa9878a8d59c41 |
| institution | DOAJ |
| issn | 1999-4923 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj-art-a1ccf10d49e04e6fbbaa9878a8d59c412025-08-20T03:14:42ZengMDPI AGPharmaceutics1999-49232025-05-0117563510.3390/pharmaceutics17050635The Regulatory Environment Surrounding Cannabis Medicines in the EU, the USA, and AustraliaClaudia Jardim0M. Begoña Delgado-Charro1Department of Life Sciences, University of Bath, Bath BA2 7AY, UKDepartment of Life Sciences, University of Bath, Bath BA2 7AY, UK<b>Background/Objectives</b>: 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. <b>Methods</b>: 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. <b>Results</b>: 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.https://www.mdpi.com/1999-4923/17/5/635medicinal cannabisregulationcannabidioltetrahydrocannabinolEpidyolex™ |
| spellingShingle | Claudia Jardim M. Begoña Delgado-Charro The Regulatory Environment Surrounding Cannabis Medicines in the EU, the USA, and Australia Pharmaceutics medicinal cannabis regulation cannabidiol tetrahydrocannabinol Epidyolex™ |
| title | The Regulatory Environment Surrounding Cannabis Medicines in the EU, the USA, and Australia |
| title_full | The Regulatory Environment Surrounding Cannabis Medicines in the EU, the USA, and Australia |
| title_fullStr | The Regulatory Environment Surrounding Cannabis Medicines in the EU, the USA, and Australia |
| title_full_unstemmed | The Regulatory Environment Surrounding Cannabis Medicines in the EU, the USA, and Australia |
| title_short | The Regulatory Environment Surrounding Cannabis Medicines in the EU, the USA, and Australia |
| title_sort | regulatory environment surrounding cannabis medicines in the eu the usa and australia |
| topic | medicinal cannabis regulation cannabidiol tetrahydrocannabinol Epidyolex™ |
| url | https://www.mdpi.com/1999-4923/17/5/635 |
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