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

September 13, 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. This notice is updated to incorporate external stakeholder feedback that was submitted during the consultation period. Mandatory eCTD format requirements for regulatory activities already implemented or effective at a future date are summarized in the table below:

Mandatory eCTD Format
List of Regulatory Activity Types
Date Regulatory Activity Type

Implemented

Division 8 (for Human Drugs only) – including Administrative (i.e. NDS, ANDS) and Labelling ONLY regulatory activities.

  • New Drug Submission (NDS)
  • Supplement to a New Drug Submission (SNDS)
  • Abbreviated New Drug Submission (ANDS)
  • Supplement to an Abbreviated New Drug Submission (SANDS)
  • Extraordinary Use New Drug Submission ( EUNDS)
  • Extraordinary Use Supplement to a New Drug Submission ( EUSNDS)
  • Extraordinary Use Abbreviated New Drug Submission (EUANDS)
  • Extraordinary Use Supplement to an Abbreviated New Drug Submission (EUSANDS)
  • New Drug Submission for Disinfectant products (NDS-D)
  • Supplement to a New Drug Submission for Disinfectant products (SNDS-D)
  • 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)
  • Pre-Submission Meeting Information (MPNDS, MPSNDS, 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 )
  • 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)
  • Post NOC - Level III Changes Form

Division 8 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
    • Post-Authorization commitments - Post market Vigilance (PA-PV)
    • Post-Authorization Act and Regulations - Post market Vigilance (REG-PV)
    • Issue Related Summary Report (IRSR-PV)
    • Risk Communication - Post market Vigilance (RC-PV)
    • Patient Safety/Advertising Ad-Hoc Post market requests (PSA-PV)

Effective January 1, 2020

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 transaction has been filed by a Sponsor for one of the regulatory activity types listed above, subsequent regulatory transactions are also mandatory in eCTD format.

If a sponsor is unable to use eCTD format for a regulatory activity that has been identified in the table above, 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:

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:

The rationale for the exemption must include appropriate justification in order to be accepted. For example:

  • Detailed explanation of the challenges related to submitting in eCTD format specific to the product; or
  • Reason(s) the sponsor is unable to file in eCTD format at the anticipated date of filing. This must also include the sponsor’s transition plan for submitting subsequent regulatory activities and transactions in eCTD format.

The following regulatory activity types are recommended in eCTD format (not mandatory). Therefore, if sponsors are unable to file them in eCTD format, a request for exemption is not required.

Recommended in eCTD Format (not mandatory)
List of Regulatory Activity Types

Division 5

  • Pre-Clinical Trial Application Consultation Meeting
  • Clinical Trial Applications (CTA)
  • Clinical Trial Application - Amendments (CTA-A) - with a 7 day administrative or a 30 day default performance standard, where the initial CTA or CTA-A has been filed after June 30, 2016.

Division 1 (Prescription and non-Prescription Human Drugs)

  • Application for Drug Identification Number (DINA)
  • Application for Drug Identification Number - Biologic (DINB)
  • Application for Drug Identification Number - Disinfectant (DIND)
  • Application for Drug Identification Number - Category IV Product (DINF)
  • Post-Authorization Division 1 Change (PDC)
  • Post-Authorization Division 1 Change - Biologic (PDC-B)
  • Post-DIN Notification (for DINA only)
  • Yearly Biologic Product Report (YBPR) - Biologic
  • Pre-Submission Meeting Information (MPDIN)
  • 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
    • Post-Authorization commitments - Post market Vigilance (PA-PV)
    • Post-Authorization Act and Regulations - Post market Vigilance (REG-PV)
    • Issue Related Summary Report (IRSR-PV)
    • Risk Communication – Post market Vigilance (RC-PV)
    • Patient Safety/Advertising Ad-Hoc Post market requests (PSA-PV)

Division 8 (for Human Drugs only)

  • Undefined Regulatory Activity (UDRA)
    • Notification of Discontinued Sale (DIN cancellation)
    • Notification of interruption of sale

Master Files

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

As Health Canada continues to move towards a harmonized intake process, additional regulatory activity types (e.g. all Division 1 regulatory activities) will be mandatory in eCTD format. Health Canada will inform stakeholders in advance of making such requirements.

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 (CESG), when applicable. Refer to the CESG information page for details.

Questions regarding this notice can be sent to hc.ereview.sc@canada.ca.

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