On 25 July 2019 Health Canada released an updated version of Guidance Document: The Management of Drug Submissions and Applications. The updates follow on from an earlier consultation and reflect updated processes and procedures relating to filing a submission or application to Health Canada. These changes include:

  • a broad reorganisation of information;
  • an added section on classification of a therapeutic product (eg, as a drug, biologic, medical device or 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 or application.

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