Health Canada Overhauls Guidance for eCTD Module

Posted 11 September 2012 | By Alexander Gaffney, RAC 

Health Canada has released a new guidance document pertaining to the creation of the Canadian Module 1 backbone of the electronic Common Technical Document (eCTD), a standardized pharmaceutical review application format created by the International Conference on Harmonisation (ICH).

Canadian regulators explained that the new guidance replaces an earlier 2004 guidance of a similar name, and outlines the process by which industry can create a regional backbone file. The files are then used in the preparation, filing and regulatory review of a drug product.

Since the release of the 2004 guidance, Health Canada said it has begun to receive large numbers of eCTD applications, which have allowed it to learn a great deal about best practices. Regulators say the new guidance reflects a more nuanced approach to regulations, as well as the agency's desire to be ready for future changes as well.

To the latter point, Health Canada said it will adopt the World Wide Web Consortium (W3C) Schema approach for extensible markup language (XML) data used in the backbone file. Much of the guidance describes how to prepare the file using the W3C XML data format, including elements, tags, language, sequence descriptions and headings.

Health Canada said it will no longer accept eCTD Module 1 applications using the old CTD module after 31 March 2013. Applications using the new W3C module will be accepted starting 30 September 2012.

Read more:

Health Canada - Notice - Guidance Document: Creation of the Canadian Module 1 Backbone

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