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Health Canada updates Guidance Document: The Management of Drug Submissions and Applications

On July 25, 2019, Health Canada released an updated version of the Guidance Document: The Management of Drug Submissions and Applications. The updates follow from an earlier consultation and reflect updated processes and procedures related to filing a submission or application to Health Canada. These changes include a broad reorganization of information, an added section on classification of a therapeutic product (e.g., as a drug, biologic, a medical device or a combination product), and modified times to respond to a clarification request during a scientific review, which are based on the type and performance standard of the submission/application.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.