On February 3rd, 2016, Health Canada announced a revision to the guidance on Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format, which was published in September 2015, to include Division 8 drugs and Clinical Trial regulatory activities in “non-eCTD electronic-only” format.
This document outlines the filing requirements and provides guidance on the structure, content and format of regulatory activities filed in “non-eCTD electronic-only” format.
Importantly, Health Canada now requires that a cover letter, in both electronic format and paper format, be included for regulatory activities in “non-eCTD electronic-only” format provided on media in an effort to facilitate identification of the content of the media.
In an attempt to ensure review efficiency, Health Canada requests the content of the electronic media be organized in a folder structure, and discusses specific structure errors to avoid in this guidance document. The guidance also outlines unacceptable file formats and specific types of media to use with the “non-eCTD electronic only” format.
This guidance has been released with the purpose of reducing regulatory burden on industry and assist in the transition to an electronic environment.
This guidance also includes a schedule for when Health Canada will no longer accept paper submissions that do not meeting the requirements set out in this guidance:
(and subsequent transactions)
|Paper will no longer be accepted as of:
|Division 1a (i.e. DINA, DINB…)||January 1st, 2016|
|Division 5 (i.e. CTA, CTA-N…)||June 1st, 2016|
|Division 8a (i.e. NDS, ANDS…)||June 1st, 2016|
|DSUR||Already in effect|
|Post-market Vigilance Data||Already in effect|
|Level III forms||Already in effect|
|DMF (New DMFs, DMF Updatesb, Transactions related to existing DMFsc)||January 1st, 2016|
|By March 31, 2016, all existing DMFs in paper format must be replaced by a complete DMF conversion in an electronic- only format.|
For further information refer to Health Canada’s Guidance Document: Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format.
A copy of this guidance document can be accessed by sending a request to Health Canada here: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/gd_prep_non_ectd_ld-eng.php