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:

Regulatory Activity Types Required in Mandatory eCTD Format by Date
January 1, 2018

Division 8 (for Human Drugs only)

  • New Drug Submission (NDS)
  • Supplement to a New Drug Submission (SNDS)
  • Abbreviated New Drug Submission (ANDS)
  • Supplement to an Abbreviated New Drug Submission (SANDS)
June 1, 2019

Remainder of Division 8 (for Human Drugs and Disinfectants only)

  • Extraordinary Use New Drug Submission (EU NDS)
  • Extraordinary Use Supplement to a New Drug Submission (EU SNDS)
  • Supplement to a New Drug Submission-Confirmatory (SNDS-C)
  • Notifiable Change (NC)
  • Request for Priority Review Status for NDS or SNDS
  • Yearly Biologic Product Report (YBPR)
  • Periodic Safety Update Report - Confirmatory (PSUR-C) or Periodic Benefit Risk Evaluation Report - Confirmatory (PBRER-C) when provided to TPD, BGTD or NNHPD - submitted to support the fulfilment of a Notice of Compliance with Conditions (NOC/c).
  • Pre-Submission Meeting Information (MPNDS, MPSNDS, MPDIN, or MPNC)
  • Undefined Regulatory Activity (UDRA) - with the exception of Notification of Discontinued Sale (DIN cancellation) and Notification of interruption of sale.
  • Development Safety Update Report (DSUR) when provided as a standalone regulatory activity to Therapeutic Products Directorate (TPD), Biologics and Genetic Therapies Directorate (BGTD) or Natural and Non-prescription Health Products Directorate (NNHPD).
  • Post NOC - Level III Changes Form
  • Including
    • Administrative regulatory activities (i.e. NDS, ANDS),
    • Labelling ONLY regulatory activities
June 1, 2019

Post-market Vigilance Data (Human Drugs only)

  • Periodic Safety Update Report (PSUR) or Periodic Benefit Risk Evaluation Report (PBRER) when provided to the Marketed Health Products Directorate (MHPD)
  • Risk Management Plan (RMP), when provided to MHPD
  • Other Post-market Vigilance data (Undefined Data Post-market Vigilance (UDPV) requested by MHPD
    • Risk communication document (e.g., Dear Health Care Professional Letter, dissemination lists, Proposed Dissemination Strategy) should be sent to the Office of Submissions and Intellectual Property (OSIP) with an electronic convenience copy being provided directly to MHPD via email
    • Post-market Surveillance (e.g., Issue-related Summary Reports, Line Listings, Registry Reports, Clinical Study Reports, or Patient Exposure Data)
    • Benefit Risk Assessment
    • Response to MHPD Requests for Additional Information
    • Notification of Change in benefit-risk profile (under sections C.01.018(3) and (4) of the Food and Drug Regulations)
    • Meetings regarding post marketing issues with MHPD

September 1, 2019

(to be confirmed)

Division 1 (applies to Prescription Drugs only)

  • Application for Drug Identification Number (DINA)
  • Application for Drug Identification Number - Biologic (DINB)
  • Post-Authorization Division 1 Change (PDC)
  • Post-Authorization Division 1 Change - Biologics (PDC-B)
  • Post-DIN Notification (for DINA only)

Master Files

  • New Type I Master Files - Drug Substance
  • New Type II Master Files - Container Closure Systems and Components
  • New Type III Master Files - Excipients
  • New Type IV Master Files - Drug Product

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

Email body:

  • 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.

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