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Canada Issues Final Guidance on Master Files


Health Canada has released a final guidance document on “Master Files (MFs) – Procedures and Administrative Requirements.” The Guidance, released on April 28, 2017, replaces the 2008 Draft Guidance Document – Drug Master Files (DMFs).

The new guidance focuses, in a large part, on how to format a master file and eliminates many of the requirements that were in the draft guidance. For example, previously DMFs needed to be updated biannually, while the new guidance only requires that MFs be updated when certain changes are made.

Health Canada explains that changes in the new guidance document “are intended to create greater alignment with the procedures used internationally for the management of MFs,” and that the guidance includes process changes that “are less cumbersome on industry and Health Canada.” The fees associated with these new process changes—along with the implementation date—will be announced in the Canada Gazette.