Health Canada is the federal department responsible for regulating drugs, medical devices, and other health products in Canada. New drugs, biologics, medical devices or natural health products must meet rigorous standards of safety, efficacy, and quality before they can be approved for marketing and sale in Canada.
The regulatory submission process in Canada can be complex and involves several stages, such as:
Pre-Clinical Testing, Clinical Trials, New Drug Submissions (NDS), Medical Device License Applications (MDL) or Product License.
The regulatory review process may involve several rounds of questions and answers between Health Canada and the applicant. Only when a product is found to be safe and effective, Health Canada grants approval for marketing and sale in Canada.
This course provides fundamental knowledge of the Canadian Pharmaceutical Drug, Biologics, Medical Device and Natural Health Product Regulations. It is designed to provide an overview of the regulatory and lifecycle management requirements for pharmaceuticals and medical devices in Canada.
Learning points:
- Health Canada Organization and Canadian Regulatory Framework
- Regulatory Requirements for New Drugs
- Regulatory Requirements for Biologics
- Regulatory Requirements for Medical Devices
- Regulatory Requirements for Natural Health Products
- Intellectual Property
- Labeling, Advertising and Promotion