Health Canada recently announced revised validation rules for regulatory transactions for electronic Common Technical Document (eCTD) submissions.
In a notice posted to its website, Health Canada gave advance warning that the agency is considering an eCTD filing requirement, or eCTD mandate, that would take effect as early as January 1, 2018. Health Canada is asking for stakeholders to submit comments by August 31, 2016. Comments can be sent to firstname.lastname@example.org.
The U.S. FDA and Health Canada have each updated their submission requirements for Drug Master Files (DMFs). Understanding each agency’s requirements will be critical to compliance in the coming months as eCTD mandates go into effect.
Traditionally, a pharmaceutical company would seek to have a drug approved in one region, and then move to other regions around the world to seek approval. Typically, companies would seek approval in their country of origin, then pursue the biggest markets, and finally focus on the rest of the world. The advent of CTD provided a common organizational structure to create submissions around the world. The ability to reuse large parts of...
As adoption of the Common Technical Document and the eCTD has progressed through the regions, variations in the content and structure of the dossier/application requirements have emerged, making submissions regionally different. This slows the preparation of submission content and delivery, and lobbies against submission efficiency aiding a rapid health product development timeline. Harmonized submission content and structure are lofty goals that often never realistically and unilaterally enter the streamlined equation for product development.