Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications

Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications The Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. This document provides guidance on the regulatory obligations pursuant to Part C, Division 5 of the Regulations, Drugs for Clinical Trials Involving Human Subjects. 2021-06-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidance documentclinical trialclinical trial applicationsFood and Drugs ActFood and Drug Regulationshuman clinical trialsregulatory obligationsdu+H36gs for clinical trials involving human subjects Guidance Document For Clinical Trial Sponsors: Clinical Trial ApplicationsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/clinical-trial-sponsors-applications.html#a1 Guidance Document For Clinical Trial Sponsors: Clinical Trial ApplicationsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/essais-cliniques/promoteurs-essais-cliniques-demandes.html#a1

The Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. This document provides guidance on the regulatory obligations pursuant to Part C, Division 5 of the Regulations, Drugs for Clinical Trials Involving Human Subjects.

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