Ask Cato: Health Canada Increases Acceptance of eCTD Electronic-only Filings

Late last week, Health Canada (HC) announced that it is further expanding its acceptance of regulatory submissions in the eCTD electronic-only format. In addition the submission types already accepted in eCTD electronic-only format (including those added to the list earlier this year), HC will now also accept these submission types:

■ Request for Priority Review Status: New Drug Submissions (PRNDS) and Supplement toa New Drug Submission (PRSNDS)
■ Pre-Submission Meeting Information
■ Drug Identification Number Application (DINA)
■ Drug Identification Number Application – Biologic (DINB)

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Ask Cato: Health Canada Increases Acceptance of eCTD Electronic-only Filings