Health Canada (HC) again postpones the mandatory deadline for Drug Master File (DMF) submissions in electronic Common Technical Document (eCTD) format. Referring to the authority’s May 2018 notification, the earlier deadline was Jan 1, 2019 which later got postponed to Sep 01, 2019.
April 19, 2017 Health Authority Updates
As said and done for many times till now, the United Sates Food and Drug Administration (USFDA) has set a compliance deadline for eCTD (electronic common technical document) submissions. The deadline for the first phase is on 5th May 2017 and for the second phase, it is on 5th May 2018. What’s there to reconsider now?
Decode the Health Canada, and US FDA new DMF Submission Mandates
Are you a DMF holder willing to submit your paper Drug Master Files (DMFs) to Health Canada? Or are you looking for a paper DMF submission partner?