Canada

Health Canada does not yet accept eCTD v4.0; v3.2.2 remains the only accepted eCTD format. Health Canada ran a public consultation on the Draft Guidance Document: Canadian Module 1 Technical Implementation Guide for the eCTD v4.0 Format from 26 June to 26 August 2019 (now closed). The draft explains how to apply the ICH eCTD v4.0 specifications to Health Canada Module 1 submission content. No v4.0 implementation date has been announced. The ICH regional implementation table projects Canada for pilot in 2027–2028, voluntary in 2028 and mandatory in 2030, but this timeline is not confirmed by Health Canada.

v4.0 in Canada is still at the draft-consultation stage, with no acceptance or mandatory timeline; existing v3.2.2 filings are unaffected and remain valid. Watch for Health Canada's v4.0 implementation notices; do not hold back current v3.2.2 submissions waiting for v4.0.

Canada's currently operating eCTD version, which companies are required to use, built on the ICH eCTD specification v3.2.2. Health Canada requires submissions to be filed electronically; eCTD is the mandatory or recommended format depending on the regulatory activity type, with a non-eCTD electronic format available for other activities. Canadian Module 1 is built per the 'Creation of the Canadian Module 1 Backbone' guidance using Canadian Module 1 Schema Version 2.2 (based on the eCTD specification 3.2.2). Health Canada has accepted submissions built with the revised M1 Schema v2.2 since 30 September 2012, and stopped accepting the old M1 DTD from 31 March 2013. Associated requirements include the Dossier ID request, the Electronic Submissions Gateway (ESG), and eCTD validation rules.

This is the working format for the vast majority of Canadian electronic submissions. The regional Module 1 specification, schema, document placement and validation rules are collected on Health Canada's 'Filing submissions electronically' hub; the submission channel is the ESG.