Health Canada Confirms eCTD Submissions Mandatory Effective January 1, 2018

On April 24, 2017, Health Canada reported that “In efforts to stay aligned with other regulatory authorities, in July of 2016, Health Canada announced January 1st, 2018 as the proposed date for mandatory filing of specified regulatory activities in eCTD format. This notice serves as a confirmation of this date…Please be advised that exemption from the mandatory eCTD format requirement will be considered on a case by case basis. A request for an individual product exemption should be submitted, by email, to ereview@hc-sc.gc.ca. The subject line of the email should be “Mandatory eCTD Format – Exemption”. The content of the email request should contain the company name, product name, regulatory activity type, anticipated date of filing, rationale for the exemption as well as an intended plan for converting to eCTD format.” Click here for the full story or here to contact PDG for help with your request for an exemption.