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Pharmaceuticals / Submissions and Approvals

Health Canada Mandates eCTD Format for New Drug Submissions Starting January 2018

May 1, 2017
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Health Canada confirmed this week that, starting Jan. 1, 2018, the agency will require regulatory filings in the eCTD format, including new drug submissions, supplements and abbreviated applications.

The agency is recommending, but not requiring, the electronic format for drug master files, clinical trial applications and drug identification number applications. Exemption from the requirement will be considered on a case by case basis.

Health Canada has been accepting eCTD filings since 2004; as of December 2016, 84 percent of regulatory activities for human drugs have been provided the format, the agency said.

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