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.
• Drug Identification Number Application (DINA) and Drug Identification Number Application - Biologic (DINB): The information provided in support of a DINA or a DINB application should be in the CTD format as outlined in the 2003 Draft Guidance to Industry: Preparation of New Drug Submissions in the CTD Format (click here). Sponsors filing a DINA/DINB application in eCTD format for the first time are strongly recommended to request a technical pre-submission consultation with Health Canada

In addition, further instructions have been included in the corresponding Notice from Health Canada (file number 11-117819-54) for submission types that are already in scope of eCTD-only submissions.  The Notice is available for download from Health Canada's website (see link at the bottom of this article).

[Source: Health Canada]

Related News:

 Health Canada further increases scope of submissions beeing accepted in eCTD-only format - 25.05.2011 10:15

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