December 28, 2016
Reference number: 16-115079-298
Health Canada is pleased to announce that effective immediately, the scope of the Common Electronic Submissions Gateway (CESG) is being expanded to include first transactions for all regulatory activities prepared in the electronic Common Technical Document (eCTD) format.
Effective January 1st, 2017, as previously announced, the CESG will be mandatory for all regulatory transactions under 10GB in size (including first transactions) prepared in the eCTD format. 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 10 GB 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.
Sponsors are also encouraged to refer to the Frequently Asked Questions – Common Electronic Submission Gateway (CESG FAQ)document for future updates.
Questions or comments can be sent to firstname.lastname@example.org.