Health Canada has released the revised draft guidance "Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format" for consultation (click here for the new draft revision).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 The revised version will replace the 2003 Draft Guidance for Industry: "Preparation of New Drug Submissions in the CTD Format" (click here for the 2003 draft version) as soon as it will be finalized.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".
To find more information please click here: Exalon:Health Canada releases draft guidance on Preparation of Drug Submissions and Applications in the CTD Format for consultation
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