Clinical Trial Regulatory Activities in eCTD
Author: Preetha Prabhu
On February 19, 2020, Health Canada announced that the pilot for Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format had concluded on August 31, 2019. The pilot was deemed successful and the implementation of Clinical Trial regulatory activities in eCTD format will begin immediately.
- 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.
- 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.
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.
- Prior to filing a Clinical Trial regulatory transaction in eCTD format, each company must file a sample transaction to Health Canada in accordance with the eCTD guidance document.
- Health Canada recommends a Pre-technical meeting for companies using eCTD for the first time.
- Once Health Canada finds the eCTD sample acceptable, companies can request a Dossier Identifier (e123456) via the Dossier Request Form for Clinical Trials dossiers, available on the Filing Submissions Electronically page.
New Guidance Documents:
Health Canada developed new documents to support companies in filing clinical trial regulatory transactions in eCTD format. Refer to the Health Canada Filing Submissions Electronically page where the following documents will be available:
- Life Cycle Management at the Document Layer for eCTD Clinical Trial Regulatory Activities.
- Clinical Trial Applications in eCTD format (available upon request via email.
- Table of Clinical Trial Regulatory Transaction (sequence) Descriptions.
Notice: Implementation of eCTD for clinical trial regulatory activities (dated Feb. 19, 2020) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-implementation-ectd-clinical-trial-regulatory-activities.html