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

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 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. 2023-10-29 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetynotice to stakeholdersclarification of requirementsFood-and-Drug RegulationsControlled Drugs-and-Substances Actclinical-research with psilocybin Notice to Stakeholders – Clarification of Requirements under the Food and Drug Regulations and the Controlled Drugs and Substances Act When Conducting Clinical Research with PsilocybinHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-clarification-requirements-conducting-clinical-research-psilocybin.html Notice to Stakeholders – Clarification of Requirements under the Food and Drug Regulations and the Controlled Drugs and Substances Act When Conducting Clinical Research with PsilocybinHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/annonces/avis-clarification-exigences-realisation-recherche-clinique-psilocybine.html

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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