As previously reported, Health Canada announced January 1, 2018 as the proposed date for mandatory filing of specified regulatory activity. On January 12, 2018, Health Canada published the Updated: Notice - Mandatory use of the Electronic Common Technical Document (eCTD) format serving as confirmation of that date. All new drug submission (NDS), supplementary new drug submission (SNDS), abbreviated new drug submission (ANDS) and supplemental abbreviated new drug submission (SANDS) regulatory activities for human drugs, as well as additional information and subsequent regulatory activities/transactions, must be filed in eCTD format as of January 1, 2018. Exemption requests must be submitted, and will be considered on a case-by-case basis.
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