Canadian, UK and US regulatory horizons: navigating the approval and compliance landscape for psychedelic-assisted treatment

A webinar presented by the IBA Healthcare and Life Sciences Law Committee and supported by the European Regional Forum, the IBA Product Law and Advertising Committee and the IBA International Commerce and Distribution Committee.

Topics will include:

• The FDA, MHRA and Health Canada's role: Explore the rigorous approval mechanisms for psychedelic substances by these agencies, highlighting the nuances involved in bringing such treatments to market.
• Rescheduling psychedelics: Understand the timing and processes behind the US DEA and Canadian RCMP's potential rescheduling of psychedelics, in the event of regulatory endorsement.
• Risk Evaluation and Mitigation Strategies (REMS): Delve into REMS and its expected components, like healthcare training and informed consent protocols, that could shape the future of psychedelic-assisted treatment.
• Compliance and international impact: Review key compliance factors and consider the broader repercussions on international treaties if psychedelics gain regulatory acceptance.
• Global clinical trials: Discuss intriguing examples of psychedelic-assisted treatment trials around the world, offering insights into the therapeutic promise and challenges faced by researchers.