Health Canada expands the scope of regulatory activity types for mandatory use of eCTD

Health Canada News

Health Canada expands the scope of regulatory activity types for mandatory use of eCTD

Since January 2018, eCTD is already required for:

  • New Drug Submission (NDS);
  • Supplement to a New Drug Submission (SNDS);
  • Abbreviated New Drug Submission (ANDS);
  • Supplement to an Abbreviated New Drug Submission (SANDS).

From 1st June 2019, Health Canada will also request the Remainder of Division 8 activities and Post-market Vigilance Data (for Human Drugs only) in eCTD format:

  • Extraordinary Use New Drug Submission (EU NDS) and Supplement (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
  • 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

From 1st September 2019, it is expected that all Division 1 activities and DMFs need to be submitted in eCTD format.

Asphalion has extensive experience with publishing in eCTD format. If you have any question, please contact us at [email protected].

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