Canadian submission requirement updates

By 2. June 2016Blog

Since January 1st 2016, all Submission new DMF submissions to Health Canada have to be submitted in an electronic format called “non eCTD electronic-only”. In addition to the January 1st deadline, all existing DMF’s have to be replaced by an electronic version by March 31st 2016.

The “non eCTD electronic-only” is very similar in structure to the existing eCTD dossier format in terms of folder structure and folder naming, however does not implement the complexities of lifecycle managing documents within the eCTD XML structure.
Health Canada clearly communicates the intention to move all regulatory activities into the eCTD guideline conforming with the global standard, so this step seems to be a interims action to prepare all MAH’s and submitting organizations for electronic submissions. The guideline specifies the following:

Future refinements and subsequent iterations of this guidance document will continue to be necessary as a result of the transition from paper format to electronic format.

Health Canada would like to provide an advanced notice that an implementation date for the mandatory requirement of filing regulatory activities in eCTD format is currently being considered for regulatory activities in scope of the Guidance Document: Preparation of Drug Regulatory Activities in the eCTD Format. This is to keep aligned with other regulatory authorities such as Food and Drug Administration (FDA) and European Medicines Agency (EMA). Questions or comments regarding this advanced

notice can be sent to ereview@hc-sc.gc.ca.

In addition to the DMF requirements, other deadlines including other submission types have been clearly outlined as well. The table below outlines the transition from paper to electronic format per submission type:

Submission type Deadline
Division 1 (i.e. DINA, DINB…) January 1st, 2016
DMF January 1st, 2016
Division 5 (i.e. CTA, CTA-N…) June 1st, 2016
Division 8 (i.e. NDS, ANDS…) June 1st, 2016
DSUR Already in effect
Post-market Vigilance Data Already in effect
Level III forms Already in effect
DNF Already in effect

Should you have any questions regarding the Canadian transition phases, please contact us via info@cunesoft.com – we will be happy to help you with your digital transformation.

Daniel Koppers

Author Daniel Koppers

Cunesoft CTO, He has more than 7 years experience with software development and project management. Moreover, he has a deep knowledge of life sciences and regulated industries. His previous employers include Nextdocs and Adlib Software. He has a degree in business informatics.

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