Health Canada confirms mandatory use of eCTD format from 1st January 2018

From the start of next year, Health Canada will only accept eCTD submissions for New Drug Submissions (NDS), Abbreviated New Drug Submissions (ANDS) and supplemental submissions to both application types.

Exemption from the mandatory eCTD format requirement is possible and will be considered on a case-by-case basis.  Such a request will need a rationale for the exemption as well as a proposed plan for converting to eCTD format in the future.

eCTD format is recommended but will not be mandatory for master files, clinical trial applications (eCTD CTA pilot only), Drug Identification Number (DIN) applications and post-authorization division 1 changes (PDC) for human drugs.

Submission of dossiers for veterinary drugs and medical devices remain out-of-scope for eCTD format so they must be filed in non-eCTD electronic format.

To read the announcement from Health Canada, click here.