Notice: eCTD Pilot for Clinical Trial Regulatory Activities - Extension
December 19 2017
Our file number: 17-114361-659
Health Canada is announcing an extension to the eCTD pilot for clinical trial regulatory activities in electronic common technical document (eCTD) format. The objective of this extension is to provide further opportunity for sponsors to participate in the pilot project, thus enabling more comprehensive experience using eCTD format for clinical trial regulatory activities, for both Health Canada as well as external stakeholders.
Since June 1st, 2016, Health Canada has stopped accepting paper copies of clinical trial regulatory activities and their related transactions. The accepted format for these transactions is “non-eCTD electronic-only”; the Guidance Document: Preparation of Drug Regulatory Activities in “Non-eCTD Electronic-Only” Format contains detailed information on filing regulatory activities or transactions in this format.
With the exception of regulatory activities filed as part of this pilot project, Health Canada currently does not accept clinical trial regulatory activities in eCTD format. This pilot will assist Health Canada and sponsors to further 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 determine broader acceptance of clinical trial regulatory activities and transactions in eCTD format.
Sponsors are encouraged to participate in this pilot project. 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 participants at a future date.
1. Who can apply for participation in the eCTD Pilot for Clinical Trials regulatory activities?
- Prior to expressing an interest to participate in this phase of the pilot, sponsors must ensure they have one or more Clinical Trial Applications (CTAs) or eligible Clinical Trial Application - Amendments (CTA-As) with either a 7 day administrative or a 30 day default performance standard, to be submitted during the period of September 1st, 2017 to March 31st, 2018.
- Sponsors must commit to the following requirements, if selected to participate in the pilot project:
- All transactions provided during the pilot must be sent via the CESG; no other form of transmission will be accepted.
- The first transaction in eCTD format can be:
- A CTA, with a 7 day administrative or a 30 day default performance standard; or
- A CTA-A, with a 7 day administrative or a 30 day default performance standard, in eCTD format where the initial CTA or CTA-A has been filed after June 30, 2016.
- Once a participant has filed a regulatory activity in eCTD format, all additional information and subsequent regulatory activities/transactions [CTA-A, CTA-Notification (CTA-N), Pre-CTA Consultation meeting (Pre-CTA) and Clinical Trial Site Information (CTSI) Forms] must also be filed in eCTD format. Participants must not convert back to “non-eCTD electronic-only” format.
- Participants 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 interested in participating must express their interest by providing:
- A written request to participate in this phase of 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 September 1st, 2017 to March 31st, 2018, 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)
- Sponsors currently participating in the pilot can update their existing list of planned CTAs and CTA-As at any time.
Questions related to this notice should be directed via email to eReview@hc-sc.gc.ca.
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