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.
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