CA: Health Canada releases the final version of their eCTD guidance

Health Canada announced the availability of the final version of their eCTD guidance. The "Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format" is available on the website of Health Canada (see link below). The guidance document defines the electronic format requirements, and provides additional guidance on the structure, content, and format of information to be included in submissions in eCTD format. It also includes extensive discussion of the life cycle management of submissions.

An "Isssue Summary" document has also been released to detail the issues raised by industry stakeholders in their comments on the previous draft version of the Guidance and to explain how the current version of that document addresses those issues.

It is recommended to consult the guidance together with the ICH eCTD specification 3.2.2 and Health Canada´s Guidance for Industry: Creation of the Canadian Module 1 eCTD Backbone File.

It should be emphasized however, that current eCTD submissions must be accompanied either by a complete paper copy in CTD format ("co-submission" filing format)  or with a partial paper-based submission ("hybrid submission" pilot project). Currently, electronic-only submissions are not accepted. Plans for accepting electronic-only submissions will be announced once sufficient experience has been aquired during the hybrid submission pilot project.

[Source: Health Canada website]

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