News Archive

Health Canada releases information regarding the electronic Submission Gateway

07.02.2014

Health Canada (HC) has released the long awaited information on how to use the electronic Submission Gateway (ESG) for electronic submissions sent to HC (see here). The Canadian...[more]

Health Canada revises eCTD Module 1 guideline

21.09.2012
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Health Canada has revised their national guidance document "Creation of the Canadian Module 1 Backbone". The updated version has been published on September 07 and will...[more]

Health Canada finalises CTD guidance and released Module 1 eCTD schema version 2.2

17.07.2012
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Health Canada has recently finalized their Guidance Document: "Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format"....[more]

Health Canada terminates Non-eCTD Hyprid Pilot phase by end of March 2013

27.04.2012
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Health Canada has announced that the Non-eCTD Hybrid Pilot phase will be terminated end of March 2013. The Non-eCTD Hybrid Pilot commenced about two years...[more]

Health Canada releases Draft for consultation: Preparation of Drug Regulatory Activities in eCTD and Creation of Canadian Module 1 Backbone

05.04.2012
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Health Canada has released a set of new draft guidances together with a new draft verson of their national Module 1 schema version for a 60-day public consultation...[more]

Health Canada increases scope of submissions being accepted in eCTD electronic-only filing format

04.10.2011
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Health Canada has further increased it's scope of submissions that are accepted in eCTD-only format. In addition to the announcement in May this year (see our previous News...[more]

Health Canada releases draft guidance on Preparation of Drug Submissions and Applications in the CTD Format for consultation

26.08.2011
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Health Canada has released the revised draft guidance "Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format" for consultation...[more]

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