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Health Canada updated notice for Mandatory use of eCTD Format

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Health Canada has updated the timeline for Mandatory Use of eCTD Format for Types of Regulatory Activity.

From since 2004, Health Canada is accepting regulatory activities in eCTD format. As of December 2018, 93 percent of regulatory activities (Part C, Division 8 of the Food and Drug Regulations, for human drugs) have been submitted in eCTD format.

  1. Regulatory Activity Types Required in Mandatory eCTD Format;
Date Regulatory Activity Types Required in Mandatory eCTD Format
January 1, 2018 Division 8 (for Human Drugs only)

  • NDS, SNDS, ANDS and SANDS
June 1, 2019 Remainder of Division 8 (for Human Drugs only)

  • EU NDS, EU SNDS, SNDS-C Notifiable Change (NC) and Request for Priority Review Status for NDS or SNDS
  • Yearly Biologic Product Report (YBPR)
  • PSUR-C or PBRER-C when provided to TPD, BGTD or NNHPD – submitted to support the fulfilment of a NOC/c
  • Pre-Submission Meeting Information (MPNDS, MPSNDS, MPDIN, or MPNC)
  • Undefined Regulatory Activity (UDRA)
  • DSUR when provided as a standalone regulatory activity to TPD, BGTD or 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)

  • PSUR or 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
    • Post-market Surveillance
    • Benefit Risk Assessment
    • Response to MHPD Requests for Additional Information
    • Notification of Change in benefit-risk profile
    • Meetings regarding post marketing issues with MHPD
September 1, 2019

(to be confirmed)

 Division 1

  • Application for DINA and DINB
  • PDC and PDC-B
  • Post-DIN Notification (for DINA only)

Master Files

  • New Type I, II, III and IV Master Files (DMF)
  1. Regulatory Activity Types Not Mandatory in eCTD Format but Recommended;
  • 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)

 

  1. Regulatory Activity Types Not Required in eCTD Format – Exemption (must be filed in “non-eCTD electronic-only” format)
  • Medical Devices
  • Veterinary Drugs

Team Masuu has qualified and experienced Regulatory Operations professionals who provide end to end eCTD publishing support and services throughout the life-cycle of product

For more details please reach us at info@ectdglobal.com.