health canada new deadline

Health Canada: New Deadline for DMF in eCTD Format

In September 2019, Health Canada announced that 1st January 2020 is the new deadline for all new Master Files as well as all additional information and subsequent regulatory transactions will be mandatory in eCTD format.

In September 2019, Health Canada announced that 1st January 2020 is the new deadline for all new Master Files as well as all additional information and subsequent regulatory transactions will be mandatory in eCTD format.
October 3, 2019

In May 2018, Health Canada proposed requiring all new Canadian Drug Master Files (DMF) to be submitted in Electronic Common Technical Document (eCTD) format effective January 1, 2019. In  January 2019, the deadline for mandatory filing of DMFs in eCTD was extended to September 1, 2019. However, a February 5, 2019 notice announcing the extension states that the September 2019 deadline is “to be confirmed,” opening the possibility that it may be postponed further.

In September 2019, Health Canada announced that 1st January 2020 is the new deadline for all new Master Files as well as all additional information and subsequent regulatory transactions will be mandatory in eCTD format.

Asphalion has extensive experience with publishing in eCTD format. Our team is up to date with upcoming mandatory format and we can recommend according to timelines.

Any help you might need with the preparation of baselines, understanding the world of eCTD or choosing the right software, Asphalion would be more than happy to support you and make your eCTD journey both valuable and pleasant.

Please contact us at eCTD@asphalion.com

Search News & Events

  • Filter by category

Share

Related news and events

Christmas season greatings

Season’s Greetings

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting