Notice : Canadian Module 1 Schema Version 2.2

July 6, 2012

Our file number: 12-111813-22

Re: Canadian Module 1 Schema Version 2.2

Health Canada is pleased to announce the finalization of the Canadian Module 1 Schema Version 2.2. Amendments were made to the Canadian Module 1 Schema Version 2.1 as a result of comments received from stake holders during the 30-day consultation period ending April 30^th, 2012.

The Health Products and Food Branch (HPFB) is committed to implementing an electronic environment which will contribute to the increased efficiencies that must be achieved to deliver appropriate performance standards in the pre-market assessment of new products. Furthermore, it will contribute to effective and efficient records management. This initiative will also address the implementation of the electronic Common Technical Document (eCTD) as part of Health Canada's commitment to the International Conference on Harmonization (ICH).

In order to take full advantage of the functionality of the eCTD specifications and design, practical and efficient solutions to the transmission, receipt and processing of electronic information, the finalised version of the Extensible Markup Language (XML) schema for the Canadian Module 1 is being posted. This is required to in order to complete an eCTD drug regulatory activity for submitting to Health Canada.

The finalized Canadian Module 1 Schema Version 2.2 replaces the 2004 Canadian DTD Version 1.0. Health Canada implementation is as per the following schedule:

• As of September 30^th, 2012, Health Canada will be accepting regulatory activities built using the revised Canadian Module 1 Schema Version 2.2.
• As of March 31^st, 2013, Health Canada will no longer be accepting regulatory activities built using the old Canadian Module 1 DTD Version 1.0.

The Canadian Module 1 Schema Version 2.2 is meant to accompany the Guidance for Industry: Creation of the Canadian Module 1 Backbone for the implementation of electronic regulatory activities that are compliant with the ICH M2 eCTD specifications.

Questions and comments relating to this document should be submitted to ereview@hc-sc.gc.ca.