Implementation of eCTD for clinical trial regulatory activities

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Implementation of eCTD for clinical trial regulatory activities

On 19th February, Health Canada announced that has begun accepting the submissions of some clinical trial regulatory activities via electronic format.

Therefore, the Sponsors may utilize the electronic Common Technical Document (eCTD) format to file clinical trial information.

The use of the eCTD format for Clinical Trial regulatory activities is optional. However, 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. Sponsors cannot revert an eCTD dossier back to “non-eCTD electronic-only” format.

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-implementation-ectd-clinical-trial-regulatory-activities.html