Biologics, radio-pharmaceuticals and genetic therapies legislation and guidelines
Acts and Regulations
The Biologics and Genetics Therapies Directorate (BGTD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to ensure that the biologic or radiopharmaceutical drug and medical device combinations offered for sale in Canada are safe, effective and of high quality. The BGTD also administers fee regulations for drugs and medical devices under the authority of the Financial Administration Act. Responsibility for administration of the Assisted Human Reproduction Act has been transferred to BGTD. All Federal Acts and associated Regulations are available on the Justice Canada Web site.
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