Notice - Mandatory use of the Electronic Common Technical Document (eCTD) format
April 15, 2019
Our file number: 19-101340 - 480
The eCTD format for regulatory activities allows Health Canada to move towards a common submission intake process, standardize and improve its business processes and tools, and align its regulatory requirements with those of other international regulatory authorities. Health Canada has been accepting regulatory activities in eCTD format since 2004. As of December 2018, 93 percent of regulatory activities under Part C, Division 8 of the Food and Drug Regulations, for human drugs, have been provided in this format.
The purpose of this notice is to communicate Health Canada's intention to expand the scope of regulatory activity types where filing in eCTD format is a mandatory requirement. This notice has been updated to incorporate external stakeholder feedback that was submitted during the consultation period. The current and intended regulatory activity types (as per section 1.3 of the Guidance Document, Preparation of Drug Regulatory Activities in eCTD Format), where filing in eCTD format is a mandatory requirement, are summarized by effective date below:
|January 1, 2018||
Division 8 (for Human Drugs only)
|June 1, 2019||
Remainder of Division 8 (for Human Drugs and Disinfectants only)
|June 1, 2019||
Post-market Vigilance Data (Human Drugs only)
September 1, 2019
(to be confirmed)
Division 1 (applies to Prescription Drugs only)
It should be noted that, once an eCTD formatted regulatory activity has been filed by a Sponsor for one of the above regulatory activity types listed above, all subsequent regulatory transactions are also mandatory in that format. If a Sponsor is unable to use eCTD format for a regulatory activity that has been identified as mandatory in eCTD format, individual requests for an exemption will continue to be considered by Health Canada on a case by case basis. These requests should be submitted as per the email template below:
Subject: Mandatory eCTD Format - Exemption
- Company name:
- Product name:
- Regulatory activity type:
- Anticipated date of filing:
- Rationale for the exemption:
The following regulatory activity types are recommended in eCTD format (not mandatory). Consequently, if sponsors are unable to file them in eCTD format, a request for exemption will not be required:
- Clinical Trial Applications
- UDRA: Notification of Discontinued Sale (DIN cancellation) and Notification of interruption of sale
- Non-Prescription (over-the-counter) Human Drugs* and Disinfectants regulated under Division 1 of the Food and Drug Regulations (i.e ., DINA (over the counter products only), DIND, DINF, PDC and, Post DIN Notifications)
The conversion of existing Master Files from "non-eCTD electronic- only" format to eCTD format is also recommended, however, not mandatory. If Master Files holders are unable to convert existing MFs to eCTD format, a request for exemption is not required.
Regulatory activity types for the following product lines currently remain out of scope for filing in eCTD format; they must be filed in "non-eCTD electronic-only" format:
- Medical Devices
- Veterinary Drugs
Regulatory transactions in eCTD format should be prepared as prescribed in the Guidance Document – Preparation of Regulatory Activities in eCTD Format, and must be sent via the Common Electronic Submissions Gateway , when applicable. Refer to the Frequently Asked Questions – Common Electronic Submission Gateway (CESG FAQ ), and the Notice - Mandatory Requirements for using the Common Electronic Submissions Gateway (CESG) documents for requirements and further guidance on using the CESG.
Questions regarding this notice can be sent to firstname.lastname@example.org.
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