Notice: Mandatory Requirements for using the Common Electronic Submissions Gateway (CESG) and the Electronic Common Technical Document (eCTD) Format

July 8, 2016
Our file number: 16-107677-18

Health Canada has been accepting regulatory activities in eCTD format since 2004. As of March 2016, 85 percent of regulatory activities for Division 8 human drugs have been provided in eCTD format. Health Canada is encouraging sponsors to take advantage of the many benefits of using eCTD format.

The CESG has been in operation at Health Canada since February 2014, for a subset of regulatory activities in eCTD format. Subsequently, the scope of regulatory activities accepted via the CESG has continually and will continue to expand as the issues causing execptions are resolved. Refer to the Frequently Asked Questions - Common Electronic Submission Gateway (CESG FAQ)document for future updates.

In efforts to continue to move towards a common submission intake process, as well as to stay aligned with other regulatory authorities, Health Canada is revising the existing requirements with respect to the following:

Mandatory CESG

Health Canada would like to announce that January 1st, 2017 is the date for mandatory filing of all regulatory activities, as per the Frequently Asked Questions - Common Electronic Submission Gateway document, via the CESG for transactions under 10GB in size. Because most transactions fall within this size limit, sponsors are strongly advised to obtain CESG accounts as soon as possible.

Sponsors providing files greater than this size should continue to use media. For detailed information on how to file using media, refer to Section 3.2 (ii) of the Guidance Document - Preparation of Regulatory Activities in eCTD Format.

Health Canada intends to accept all regulatory activity types provided in eCTD format via the CESG in the near future. Refer to the Frequently Asked Questions - Common Electronic Submission Gateway (CESG FAQ) document for future updates.

Questions or comments regarding this announcement can be sent to hc_cesg_pcde_sc@hc-sc.gc.ca.

Mandatory eCTD Format

This is an advanced notice that Health Canada is considering January 1st, 2018 for mandatory filing of all New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Abreviated New Drug Submission (ANDS) , and Supplement to an Abreviated New Drug Submission (SANDS) regulatory activities (for human drugs) in eCTD format. Once a sponsor files a regulatory activity in eCTD format, all additional information and subsequent regulatory activities (such as NC, PSUR, RMP, etc.) must also be filed in eCTD format.

Comments regarding this advanced notice can be sent to ereview@hc-sc.gc.ca, by August 31st, 2016.

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