05 April 2012
Exalon: Health Canada releases Draft for consultation: Preparation of Drug Regulatory Activities in eCTD
Health Canada has released a new draft version of their guidance document "Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD)" for a 60-day consultation period. Once final, it will replace the "2009 Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document Format."
The guidance document "defines the electronic format requirements and process, as well as provides additional guidance on the structure and content of information to be included in regulatory activities in eCTD format. It provides a few examples of documents and their locations in the new structure define in the revised Canadian Module 1 Backbone".
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