Posted 25 April 2017
By Michael Mezher
Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format.
As of that date, Health Canada says that sponsors must use eCTD format for all new drug submissions (NDS) and abbreviated new drug submissions (ANDS), as well as supplements to both submission types.
The agency also notes that sponsors can request an exemption from the requirement for individual products, but says it expects companies to provide their "rationale for the exemption as well as an intended plan for converting to eCTD format."
For many sponsors, this should not be a dramatic transition. According to Health Canada, as of December 2016, 84% percent of regulatory activities for drugs are filed in eCTD format as of December 2016.
For other regulatory documents and activities, such as master files, clinical trial applications (CTA), drug identification number (DIN) applications and post-authorization division 1 changes (PDC) for human drugs, Health Canada says it recommends sponsors use eCTD format, though the format will not be mandatory.
Medical device and veterinary drug submissions, however, "remain out of scope for filing in eCTD format" and must be in "non-eCTD electronic-only" format.
And, as previously announced, Health Canada says sponsors will be required to file all electronic submissions under 10GB via the Common Electronic Submissions Gateway (CESG), while submissions over the 10GB file size limit must be submitted on physical media.