Updated: Notice - Mandatory use of the Electronic Common Technical Document (eCTD) format

February 5, 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 updated 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.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 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)
  • 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, Council For International Organizations Of Medical Sciences (CIOMS), 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

  • 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 transactions are also mandatory in that format . Any individual product exemptions from the mandatory eCTD format requirement will continue to be considered by Health Canada on a case by case basis. These requests should be submitted as per the template below:

To: hc.ereview.sc@canada.ca.

Subject: Mandatory eCTD Format - Exemption

Email body:

  • Company name:
  • Product name:
  • Regulatory activity type:
  • Anticipated date of filing:
  • Rationale for the exemption:

Filing in eCTD format is not mandatory, but recommended, for the following regulatory activity types:

  • Clinical Trial Applications (eCTD CTA pilot only ),
  • UDRA: Notification of Discontinued Sale (DIN cancellation) and Notification of interruption of sale
  • Non-Prescription Human Drugs* 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)

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 hc.ereview.sc@canada.ca.

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