The Biologics and Genetic Therapies Directorate (BGTD) applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that drugs defined by Schedule C and Schedule D of the Act for human use in Canada are safe, effective and of high quality.
The BGTD is committed to developing any new regulations, policies, and guidelines in consultation with stakeholders and interested parties. The links provided introduce the regulatory initiatives. Further information on Federal Acts and Regulations is available on the Department of Justice Canada website.
- Proposals to Amend the Food and Drug Regulations with respect to radiopharmaceuticals [2011-09-20]
- Regulations Amending the Food and Drug Regulations (1319 - New Drugs for Extraordinary Use) [2011-04-27]
- Regulations Amending the Patented Medicines (Notice of Compliance) Regulations [2011-04-27]
- Regulations Amending the Food and Drug Regulations (Positron-emitting Radiopharmaceuticals) - Project 1561 [2009-03-23]
- Movement of Regulatory Oversight for Heparin, Low Molecular Weight Heparin, and Heparinoids to the Biologics and Genetic Therapies Directorate [2007-12-19]
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