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May 28, 2004
Our file number: 04-110775-446
The Health Products and Food Branch (HPFB) is committed to implementing an electronic submission and review environment. An E-Review environment will contribute to the increased efficiencies that we must achieve 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 e-CTD specifications and design, practical and efficient solutions to the transmission, receipt and processing of electronic information, the Extensible Markup Language (XML) Document Type Definition (DTD) for the Canadian ICH eCTD Module 1 is being posted. This is required to complete an eCTD for drug submission to Health Canada. The Canadian DTD Version 0.9 was posted on this website on Dec 23, 2003 for comment. The Canadian DTD Version 1.0 is now being made available. The revised Version 1.0 is being published and supercedes Version 0.9, which is now obsolete. Changes to the Version 1.0 are cosmetic in nature and do not affect the functionality of the DTD.
The Canadian DTD Version 1.0 is meant to accompany the Guidance for Industry: Preparation of Drug Submissions in the eCTD Format for the implementation of electronic submissions that are compliant with the ICH M2 eCTD specifications.
For further information or comments please email: eReview@hc-sc.gc.ca.