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.

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Title (French) Ligne directrice à l'intention des promoteurs d'essais cliniques : Demandes d'essais cliniques
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Open Canada Date Published 2016-06-29 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["document d'orientation", "essai clinique", "demandes d'essais cliniques", "Loi sur les aliments et drogues", "Règlement sur les aliments et drogues", "essais cliniques sur l'homme", "obligations réglementaires", "du + H36gs pour les essais cliniques sur des sujets humains"], "en": ["guidance document", "clinical trial", "clinical trial applications", "Food and Drugs Act", "Food and Drug Regulations", "human clinical trials", "regulatory obligations", "du+H36gs for clinical trials involving human subjects"]}
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