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P117: Health Canada Regulatory Requirements for Clinical Trials with Cannabis and Psychedelic-Assisted Psychotherapy

Poster Presenter

Neda Gharavi

Senior Director Medical Writing & Regulatory Affairs
BioPharma Services
Canada

Objectives

To assess the regulatory requirements and procedures mandated by Health Canada for conducting clinical trials involving cannabis and psychedelic-assisted psychotherapy.

Method

A comprehensive review of Health Canada's regulations governing clinical trials with cannabis and psychedelic-assisted psychotherapy. It evaluates the licensing and approval processes for each type of research, as well as the specific risk-management measures for psychedelic drugs.

Results

Therapeutics clinical trials of cannabis and psychedelic-assisted psychotherapy fall under the Food and Drugs Regulations (FDR). Cannabis-related trials must also comply with the regulation of the Cannabis Act. Health Canada mandates the following requirements for cannabis and psychedelic drugs. Both require a federal research license from the Controlled Substances, REB Approval, a No Objection Letter (NOL) as a result of Clinical Trial Application (CTA) submission, adherence to Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). Per the FDR, Good Production Practices (GPP) and GMP are not interchangeable for therapeutic cannabis clinical trials. Cannabis-related trials must also receive a federal research licence from the Cannabis Branch of Health Canada. Health Canada may waive the need for a full set of product-specific pre-clinical studies in the Investigator's Brochure (IB) if the cannabis product is GMP-compliant and deemed safe per existing evidence. However, the IB must be updated with new information to align with ICH M3(R2) for assessing efficacy and safety. Market-authorized cannabis products may grant flexibility, permitting the IB for early trials without a full set of pre-clinical studies. Nonetheless, synthetic products or those lacking market authorization necessitate specific pre-clinical studies. Psilocybin and MDMA are widely used in clinical trials as psychedelic drugs, inducing altered states of consciousness that may impact participants' emotions which increases the psychological risks. Therefore, CTA for these drugs must include detailed risk-management measures to protect participants' safety. Health Canada mandates therapists to have proper training and license for psychedelic drugs. The authorized physician must administer these drugs and be present during the drug's effects. The therapists' qualifications including credentials, licensing status, and previous experience with psychedelic drugs, must be submitted in CTA.

Conclusion

In conclusion, our assessment of Health Canada's regulatory requirements for clinical trials involving cannabis and psychedelic-assisted psychotherapy reveals a comprehensive framework governing research in these areas. For both cannabis and psychedelic drugs, Health Canada has similar requirements regarding licensing for Controlled substances, REB approval, NOL and compliance with GCP and GMP standards. However, specific risk-management measures are required for psychedelic drugs due to their potential psychological impacts. Moreover, therapists involved in psychedelic-assisted psychotherapy trials must undergo specialized training and be licensed, with detailed qualifications documented. Despite challenges in creating product-specific Investigator's Brochures for cannabis, Health Canada emphasizes the importance of aligning with international guidelines and updating information regularly. Overall, these requirements aim to ensure the safety and efficacy of clinical trials while advancing research in these areas.