Notice: Release of draft guidance document: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format

June 26, 2019
Our file number: 19-112595-470

The above referenced draft guidance was released by Health Canada for consultation and is being posted on the website for information and comment.

This notice is accompanied by the Draft Guidance Document: Canadian Module 1 Technical Implementation Guide for the Electronic Common Technical Document (eCTD) v4.0 Format. Health Canada is seeking feedback on the Electronic Common Technical Document (eCTD) version 4.0, as the next major version of the eCTD format being considered to replace the current eCTD version 3.2.2.

Health Canada acknowledges that the upgrade to eCTD v4.0 requires advanced notice, planning and collaboration. To begin stakeholder engagement, this notice is being published along with a draft implementation guidance document.

As the project to implement eCTD v4.0 progresses, Health Canada will remain engaged with stakeholders via the Health Canada website, webinars and public forums such as the Canadian Association of Professionals in Regulatory Affairs (CAPRA) and Drug Information Association (DIA).

The following are some of the more notable benefits of eCTD v4.0:

• Separate content from format: Manage content, like lists and Common Technical Document section headings, as controlled vocabularies separate from the backbone. It is therefore possible to make administrative changes (e.g., adding new regulatory activity types or changing the Module 1 structure) without a major software update.
• Two-Way Communication: Facilitates Health Canada's ability to send regulatory transactions in eCTD format (e.g., clarification request, Notice of Compliance) back to the Sponsor via the Common Electronic Submission Gateway (CESG).
• Advanced Lifecycle Management: Supports the ability to submit one regulatory activity related to multiple dossiers, one file to replace multiple existing files, and a document to be submitted once and reused across multiple regulatory activities. It also enables the ability to modify metadata.

Next Steps

The draft Health Canada Implementation Guidance is being published for comment. The next milestones are for Health Canada to consider stakeholder feedback and consult with ICH partners and other regulatory authorities on the international rollout plan for eCTD v4.0. Once the decision to implement eCTD v4.0 has been confirmed, the Guidance Document - Preparation of Regulatory Activities in eCTD Format will be revised to reflect the new requirements.

It is also important to note that amendments to draft documents may occur as a result of regulatory consultations and subsequent deliberations within Health Canada.

Comments provided to Health Canada should be submitted no later than 60 days, in order to allow sufficient time for their assessment.

Questions regarding the draft implementation guide and this notice should be sent to hc.ereview.sc@canada.ca.