Notice: eCTD Pilot for Clinical Trial Regulatory Activities
January 18, 2017
Our file number: 16-107011-249
Health Canada is announcing a six month extension to the eCTD pilot for clinical trial regulatory activities in electronic common technical document (eCTD) format. This extension is to provide an opportunity for additional sponsors to request for participation in the pilot project, as well as to encourage the submission of a higher number of regulatory activities from existing participants.
Since June 1st, 2016, Health Canada has stopped accepting paper copies of clinical trial regulatory activities and their related transactions. The recommended format for these transactions is “non-eCTD electronic-only”. Refer to the Guidance Document: Preparation of Drug Regulatory Activities in “Non-eCTD Electronic-Only” Format for detailed guidance on filing regulatory activities or transactions in the ‘non-eCTD electronic-only” format.
Health Canada currently does not accept clinical trial regulatory activities in eCTD format. This pilot will assist Health Canada and sponsors to assess the feasibility of accepting clinical trial regulatory activities in eCTD format without jeopardizing performance standards. Lessons learned and experiences gained will be used to initiate the acceptance of clinical trial regulatory activities and transactions in eCTD format.
Eligible sponsors are encouraged to apply promptly as participation is limited on a first come first serve basis. All requests to participate in the pilot will be assessed and participants will be selected based on the requirements below. Further instructions on how to submit clinical trial regulatory activities in eCTD format will be provided to the selected participants at a future date.
1. Who can apply for participation in the eCTD Pilot for Clinical Trials regulatory activities?
- Sponsors must ensure they meet the follow requirements prior to expressing their interest to participate in the pilot project:
- Participants must have previous experience filing regulatory activities in eCTD format, with Health Canada, using the Common Electronic Submission Gateway (CESG).
- Participants must have Clinical Trial Applications (CTAs) with a 30 day default performance standard to be submitted during the period of October 1, 2016 to Sept. 30th, 2017.
- Sponsors must commit to the following requirements, if selected to participate in the pilot project:
- All new participants must be available to attend a meeting on a date selected by Health Canada.
- All transactions provided during the pilot must be sent via the CESG; no other form of transmission will be accepted.
- For the initial transaction, only CTAs with a 30 day default performance standard will be accepted (7 day administrative CTAs are outside of the scope for this pilot project).
- Once a participant files a CTA in eCTD format, all additional information and subsequent regulatory activities (Clinical Trial Application - Amendments (CTA-A), Clinical Trial Application - Notifications (CTA-N), and Clinical Trial Site Information (CTSI) Forms) for that CTA must also be filed in eCTD format. Participants should not convert back to “non-eCTD electronic-only” format.
- Participates must provide responses to clarification requests in eCTD format as per the regulatory timelines.
2. How to apply for participation in the Clinical Trials eCTD Pilot.
- Sponsors must express their interest by providing:
- A written request to participate in the pilot, via email to eReview@hc-sc.gc.ca, with the subject heading “Clinical Trial eCTD Pilot”.
- A plan listing the CTAs intended to be filed in eCTD format during the period October 1, 2016 to Sept. 30th, 2017, including the following information:
- Brand Name, Medicinal Ingredient and/or the Drug Code Name
- Intended Indication
- Month of intended filing
- Protocol Number (if known)
- Lead Directorate/Bureaux (if joint review)
- The deadline for submitting a request for participation is February 13th, 2017
Questions related to this notice should be directed via email to eReview@hc-sc.gc.ca.