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

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 Article) the following submission types are accepted in eCTD-only format (requiring only the cover letter to be submitted as paper original in addition):

Request for Priority Review Status:

New Drug Submissions (PRNDS) and Supplement to a New Drug Submission (PRSNDS): The Clinical Assessment Package filed to support a Priority Review Request should be currently filed as leaf elements under the m1-2-8-other-application-information subheading, at this time. When the related submission is filed, the priority review acceptance letter should also be filed under the m1-2-8-other-application-information subheading.

Pre-Submission Meeting Information:

As for the PRNDS and PRSNDS, the corresponding information should be currently filed as leaf elements under the m1-2-8-other-application-information subheading. For all leaf files provided as part of the Pre-Submission Meeting Package, the operation attribute in the leaf element should be “new”, with the possible exception of the Life Cycle Management (LCM) table. When a document is revised in relation to the pre-submission meeting, the operation attribute should be “replace”. Please note: Sponsors may be required to provide printed copies of the Pre-Submission Meeting Package, upon request.

For More information click here: Exalon: Health Canada increases scope of submissions being accepted in eCTD electronic-only filing format