A clinical trial application (CTA) is the request a sponsor, usually a company or a hospital or university research team, sends to Health Canada before testing a drug in people. Health Canada scientists review it to check, among other things, that the drug’s risks are minimized and participants’ interests are considered (Health Canada). Health Canada says it does not sponsor or conduct drug research itself (Health Canada).
Trials fall under Part C, Division 5 of the Food and Drug Regulations. For psilocybin, Health Canada’s 2022 notice says an application includes a protocol, an informed consent form, an Investigator’s Brochure and chemistry and manufacturing information (Health Canada notice, 2022). A research ethics board must approve the trial separately (Health Canada notice, 2022).
Psilocybin needs one more step because it is a controlled substance. Health Canada’s psilocybin page, updated 20 October 2026, says that once a trial is authorized, a separate authorization under the Controlled Substances Regulations is needed to permit its sale for clinical testing (Health Canada). This describes the process; it is not legal advice.
Sources
- Health Canada: Clinical trials and drug safety
- Health Canada notice on clinical research with psilocybin, 11 January 2022
- Health Canada: Psilocybin and psilocin
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