Canada – Implementation of eCTD for clinical trial regulatory activities

The pilot for Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format concluded on August 31, 2019. Health Canada is pleased to announce that the pilot was successful. Therefore, implementation of Clinical Trials regulatory activities in eCTD format will begin immediately for the following:

  • Pre-Clinical Trial Application Consultation Meeting (PRE-CTA)
  • Clinical Trial Applications (CTAs) with either a 7 day administrative or a 30 day default performance standard
  • Clinical Trial Applications – Amendments (CTA-As) with a 7 day administrative or a 30 day default performance standard
  • Clinical Trial Application – Notification (CTA-N)
  • All related responses and post-clearance data to the regulatory activities above

The following regulatory activities and/or transactions are out-of-scope for filing in eCTD format:

  • Clinical Trial Site Information (CTSI)
  • Development Safety Update Report (DSUR)
  • Signal assessment related requests from the Therapeutic Products Directorate/Office of Clinical Trials – Adverse Drug Reaction division  (OCT ADR)
  • Fax-Backs for the Biologics and Genetic Therapies Directorate…