Health Canada Mandates DMF Submissions in eCTD Format

Health Canada (HC) again postpones the mandatory deadline for Drug Master File (DMF) submissions in electronic Common Technical Document (eCTD) format. Referring to the authority’s May 2018 notification, the earlier deadline was Jan 1, 2019 which later got postponed to Sep 01, 2019. Now with the recent notification from the authority, the eCTD format for DMF will be effective from Jan 01, 2020.

With the new mandate, HC aims to create a common submission intake process, to streamline the existing processes, and to align the Regulatory requirements with other global Regulatory authorities. The agency also stated that the new mandate meant to educate the stakeholders in the preparation and submission of all Regulatory transactions in the eCTD format.

eCTD Mandate and Types of Master Files

To align with the HC’s new notification, DMF holders must use eCTD format for all the Regulatory activity types as mentioned below.

  • 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 Products

For the existing non-eCTD DMF applications, the authority recommends converting them to eCTD format, but the conversion is not mandatory, and an exemption will continue on a case-on-case basis.

The sponsors/stakeholders also need to note that once they file an eCTD formatted Regulatory transaction for any of the above-mentioned Regulatory activity types, subsequent transactions need to be submitted in eCTD format only. Conversion from paper-to-eCTD format isn’t easy as it includes several challenges, Sponsors/stakeholders must track the latest revisions and stay compliant while preparing and submitting DMFs to Health Canada. Stay informed to be compliant.