Implementation of Clinical Trials Regulatory Activities in eCTD Format Begins by Health Canada
After successful Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format in the pilot in August 2019, Health Canada begins implementation of Clinical Trials regulatory activities in eCTD format.
Health Canada will allow eCTD submissions specially 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
Health Canada also state that following clinical trial 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
Health Canada says that “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.”
Sponsors looking to submit clinical trial applications and related submissions using eCTD format are instructed to use the Common Electronic Submissions Gateway and follow Health Canada’s eCTD guidance.
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