Implementation of eCTD for Clinical Trial Applications in Canada

Health Canada would be accepting certain clinical trial submissions in the format of electronic common technical document (eCTD) from 19 February 2020. This comes after a successful pilot that concluded on August 2019.

This will be implemented for pre-clinical trial application consult meetings, clinical trial applications (CTAs), CTA amendments and notifications, as well as all related responses and post-clearance data.

Certain clinical trial regulatory activities and transactions are out-of-scope for filing in eCTD format.

The usage of eCTD format for clinical trial activities is optional for sponsors. Health Canada said in a statement,
“Once a sponsor files a regulatory activity in eCTD format, all additional information and subsequent regulatory transactions for the same dossier (protocol) must also be filed in eCTD format.”, further highlighting that sponsors are not able to revert an eCTD dossier to non-eCTD electronic-only format.