Notice - Submissions in Electronic Common Technical Document (eCTD) Format

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Contact: eReview

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January 27, 2010

Notice

Our file number: 10-100791-645

Submissions in Electronic Common Technical Document (eCTD) Format

Health Canada is pleased to announce the completion of the pilot for the hybrid filing format.

This Notice provides the outcome of the hybrid filing format pilot assessment, as well as the next steps for submissions in the eCTD format.

Any updates to eCTD filing requirements will not be applied retroactively to submissions pending review. Furthermore, sponsors currently preparing a submission may continue to follow the Health Canada Guidance Documents in effect prior to this Notice. However, subsequent submissions should be compiled using the most recent Guidance Documents and Notices.

Background

Health Canada is taking a structured approach towards the adoption of full electronic submissions in eCTD format. This approach will allow sponsors and Health Canada to gradually gain experience with the preparation, processing, and review of submission in eCTD format. Health Canada's goal is to implement submissions in eCTD format without any negative impacts on the review process, particularly with regards to performance targets.

1. Acceptance of submissions in eCTD format on compact discs (CDs) and digital video discs (DVDs) along with full paper-based submissions in CTD format (co-submission).
2. Acceptance of submissions in eCTD format on CDs and DVDs along with partial paper-based submissions in CTD format (hybrid submission).
3. Acceptance of submissions in eCTD format on CDs and DVDs (electronic-only submission).

Since September 2004, Health Canada has been accepting eCTD submissions in co-submission format. In June 2006, Health Canada adopted a controlled implementation for eCTD submissions in the hybrid filing format, beginning with a pilot. A hybrid submission is a submission in eCTD format that is accompanied by Modules 1 and 2 in paper-based CTD format. In December 2007, Health Canada released revisions to the criteria for participation in the hybrid filing format pilot, (Appendix F, "Pilot Implementation of the Hybrid Filing Format," of the Draft Guidance for Industry: Preparation of Drug Submissions in eCTD Format) to encourage sponsors to file submissions in this format.

Outcome of Pilot

Since June 2006, Health Canada has received 72 requests to participate in the pilot phase of the submissions in the hybrid filing format; 63 of the requests were accepted. A total of 43 hybrid submissions were received and a decision has been reached on 21 of those submissions.

A breakdown of the number of submissions received for which a decision has been reached are as follows (includes pharmaceutical and biologic submissions):

• 5 New Drug Submissions (NDS);
• 1 Priority NDS;
• 4 Supplements to a New Drug Submission (SNDS);
• 1 Priority SNDS;
• 9 Notifiable Changes (NC);
• 1 Periodic Safety Update Reports with Condition (PSUR-C).

In order to determine the success of the pilot, Health Canada monitored the progress of these hybrid submissions through the review process.

A survey questionnaire was circulated amongst the Therapeutic Products Directorate (TPD) and Biologic and Genetic Therapies Directorate (BGTD) regulatory staff who were involved in the review process of a hybrid submission. A total of 45 surveys were distributed and 21 (47%) responses were received. The survey assessed three aspects of the pilot: electronic data readiness to assess the training received; working with the docuBridge viewing tool; and working with submissions in the hybrid filing format. Respondents indicated that they were highly satisfied with reviewing electronic data using the viewing tool provided.

The review performance targets for eCTD submissions in the hybrid filing format, were consistent with the review of the paper based CTD submissions. For example the average number of days to approval for three pharmaceutical hybrid New Drug Submissions (NDS) was 389 days; it falls well within the range of approval times for paper based CTD submissions which ranged from 226 to 798 (for 2007 & 2008). After reviewing the performance times of all the hybrid submissions, it is evident that reviewing a submission in eCTD format has no negative impact on approval times.

While working with eCTD submissions, we have gained efficiencies in the review process.
Some of the benefits are listed below:

• Facilitated access to submissions;
• Enhanced navigation through submissions via table of contents, bookmarks and hyperlinks;
• Faster search/retrieval of information;
• The ability to insert highlights and annotations directly in the submission without altering the original document;
• The ability to share comments between evaluators in real-time;
• The ability to copy information from the submission and paste it into review reports.

The hybrid pilot has demonstrated that reviewers are comfortable working with electronic data in eCTD format and that eCTD submissions do not have a negative impact on the review process. Overall, the hybrid pilot was a success and we have now confirmed that Health Canada has the capacity to receive and review submissions in eCTD format.

Therefore,

• Health Canada strongly recommends electronic submissions in eCTD format;
• Effective immediately, Health Canada will no longer accept eCTD submissions in co-submission filing formats since, this was a transitional measure which does not offer a real gain in efficiency.
• Effective immediately, sponsors are no longer required to submit a request prior to filing an eCTD submission in the hybrid filing format.
  • Appendix F, "Pilot Implementation of the Hybrid Filing Format" of the Guidance for Industry: Preparation of Drug Submission in eCTD Format no longer applies as this section was developed exclusively for the hybrid pilot;
  • Sponsors filing an eCTD submission to Health Canada in the hybrid filing format for the first time, are still required to file an eCTD sample and to schedule a technical pre-submission consultation prior to filing a complete hybrid submission in eCTD format.
  • Sponsors wishing to file a hybrid submission are still asked to follow all other requirements prescribed in the Guidance for Industry: Preparation of Drug Submissions in eCTD Format;

Should you have any questions regarding the content of this notice, please contact:

Submission and Information Policy Division (SIPD)
Therapeutic Products Directorate
Health Canada
Finance Building 2
101 Tunney's Pasture Driveway
Tunney's Pasture, Address Locator 0201A1
Ottawa, Ontario
K1A 0K9
Email: ereview@hc-sc.gc.ca