From 01 September 2019, eCTD Format For Dossier Submission Will Be Mandatory For The Health Canada

Health Canada has been accepting regulatory activities in eCTD format since 2004. Now Health Canada will accept dossiers in eCTD format only from 01 September 2019 for the following applications.

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

As of December 2018, 93 percent of regulatory activities for human drugs, have been provided in this format. 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. 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.


For more detailed information refer below link.