Notice to Stakeholders – Clarification of Requirements under the Food and Drug Regulations and the Controlled Drugs and Substances Act When Conducting Clinical Research with Psilocybin (French, HTML)

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Publisher-reported update

2023-10-29

Health Canada is issuing this notice to clinical trial sponsors to clarify the approach to clinical research with psilocybin. Health Canada recognizes that conducting clinical research (i.e., research carried out on humans) is a critical step in the generation of good quality evidence needed to better understand the potential health benefits and harms associated with the therapeutic use of psilocybin.

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