Health Canada previously 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, which served as confirmation of that date.
All new drug submission, supplementary new drug submission, abbreviated new drug submission and supplemental abbreviated new drug submission regulatory activities for human drugs – as well as additional information and subsequent regulatory activities and 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.
For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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