Health Canada releases draft guidance on Preparation of Drug Submissions and Applications in the CTD Format for consultation

Health Canada has released the revised draft guidance "Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format" for consultation (click here for the new draft revision). The consultation period will last for 60 days and will end on October 7, 2011. The revised version will replace the 2003 Draft Guidance for Industry: "Preparation of New Drug Submissions in the CTD Format" (click here for the 2003 draft version) as soon as it will be finalized.

The new draft version contains extensive revisions made to the Canadian Module 1 format, allowing "for the CTD format to be used for all submission and application types filed over a product’s lifecycle". For example:

• Post-authorization commitment tracking table;
• Regional Clinical information has been added as new section 1.6. The previous section "1.6 Electronic Review Documents" has been moved to the new section "1.A Appendices"
• Clinical Trial Applications and their amendments are now included in the proposed Module 1 as new section 1.7
• Module 3.2.R.4 for Yearly Biological Product Reports added (submitted to the Biologics and Genetic Therapies Directorate only)
• Addition of clarification  to Module 5 regarding the placement of PSURs.

In the course of this initiative, Health Canada further informs that the "Guidance for Industry: Creation of the Canadian Module 1 eCTD Backbone File" and the Canadian Module 1 DTD are being updated and are targeted to be published in Winter 2011. According to Health Canada, this will "allow for the transition of eCTD submissions to the proposed Module 1 format".

[Source: Health Canada]

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