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Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically

Health Canada recently (13 May 2024) updated its guidance "Preparation of Regulatory Activities in Non-eCTD Format" (electronic Common Technical Document) format for filing submissions electronically. This guidance is crucial for drug manufacturers and sponsors to ensure that their submissions are prepared and filed correctly.

The guidance document aims to provide instructions on how to prepare and submit regulatory activities electronically to Health Canada.

It applies to drug submissions, including new drug submissions (NDS), abbreviated new drug submissions (ANDS), and supplemental new drug submissions (SNDS).

This guidance in particular provides detailed instructions on how to organize and format submissions in the non-eCTD format, including the use of bookmarks, hyperlinks, and file naming conventions. Also outlines the specific requirements for different types of submissions, such as NDS, ANDS, and SNDS, including the types of documents to include and the order in which they should be presented.

Companies are required to file submissions electronically to Health Canada in either Electronic Common Technical Document (eCTD) format or non-eCTD format, depending on the regulatory activity type. There are multiple sections in this guidance that provide detailed information on these formats and other information related to filing submissions electronically.

For the file transactions involving human drugs, the transactions must be sent through the Common Electronic Submissions Gateway (CESG) along with the Regulatory Enrolment Process (REP). REP is a common submission intake method across product lines (i.e. prescription drugs for human and veterinary use, biologics and radiopharmaceuticals for human use, medical devices for human use and disinfectants) and filling formats (i.e. eCTD and non-eCTD format).

Click this LINK to download the zip files of the folder structure for each product line as outlined. Human Drugs, Disinfectants and Clinical Trials (Division 1 and 5).

By following this guidance, stakeholders can facilitate the review process and expedite the approval of their drug submissions.


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