Description

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.

Resources

Name	Format	Description	Link
Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications	HTML		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 Applications	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/essais-cliniques/promoteurs-essais-cliniques-demandes.html#a1

Tags

Topics

Categories