Health Canada Hints at 2018 eCTD Mandate

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In a notice posted to its website, Health Canada gave advance warning that the agency is considering an eCTD filing requirement, or eCTD mandate, that would take effect as early as January 1, 2018.

Health Canada is asking for stakeholders to submit comments by August 31, 2016. Comments can be sent to ereview@hc-sc.gc.ca.

The eCTD format filing requirement would apply to the following regulatory activity types:

  • New Drug Submission (NDS)
  • Supplement to a New Drug Submission (SNDS)
  • Abbreviated New Drug Submission (ANDS)
  • Supplement to an Abbreviated New Drug Submission (SANDS)

And as is true for the US FDA, once a sponsor submitting to Health Canada files a regulatory activity in eCTD format, all subsequent submissions pertaining to that regulatory activity would also have to be in eCTD format.

In the same advanced notice, Health Canada reported that as of March 26, 2016, 85% of regulatory activities for Division 8 human drugs have been provided in eCTD format.

Author: Brandon Underwood

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