17.07.2012

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

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Health Canada has recently finalized their Guidance Document: "Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format". The guidance document should assist sponsors in the preparation of drug regulatory activities in CTD format and defines the regional requirements found in Modules 1 and 3. The recently finalized revision reflects comments form stakeholders that have been collected in an issues analysis document.

The new Module 1 will be accepted by Health Canada in CTD format from now on, for eCTD submissions the new Module 1 will be accepted as of 31st September this year. As of January 2013, Health Canada will no longer be accepting regulatory activities using the old Module 1 in CTD format and as of March 31st 2013 the old Module 1 will also no longer be accepted in eCTD format.

Please note that once a product has been moved to the new Module 1 format, it may not be reverted to the old Module 1.

To support the new Module 1 in eCTD format the corresponding eCTD schema file has been finalized in 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 30th, 2012.

[Source: Health Canada]

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