Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies - Health Canada
All drugs that are marketed in Canada are subject to the Food and Drugs Act and Regulations. The Biologics and Genetic Therapies Directorate is responsible for the review and approval of all types of drug submissions for Biological (Schedule D) and Radiopharmaceutical (Schedule C) drug products, including, but not limited to New Drug Submissions (NDSs) and Clinical Trial Applications (CTAs). For the regulatory requirements specific to Radiopharmaceutical (Schedule C to the Act) or Biological (Schedule D to the Act) drugs, please refer to Divisions 3 and 4, respectively, of Part C of the Regulations. For general regulatory requirements concerning all drugs, including Good Manufacturing Practices, please refer to Divisions 1, 1a, 2, 5 and 8 of Part C of the Regulations.
The guidance documents, policies, forms, and templates provided will aid in the preparation of drug submissions.
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