Health Canada Proposes Mandatory eCTD Requirements
With an approaching deadline of 1 January 2019, Health Canada is requesting industry input on establishing mandatory requirements for submitting drug master files (DMFs) using the electronic common technical document (eCTD) format.Use of the eCTD format is intended to facilitate DMF submissions to the regulatory authority’s Common Electronic Submissions Gateway (CESG). Health Canada believes transitioning to an electronic-only submission process will lead to more consistency.
Following the 2013 Cooperative Research and Development Agreement (CRADA) between Health Canada and the US Food and Drug Administration (FDA), CESG became a mandatory mechanism—as of 1 January 2017—for all regulatory transactions under 10GB in size using the eCTD format.
As part of the CRADA, Health Canada and FDA modified their previously developed gateways for electronic submissions about four years ago so that drugs and biological products applications can be submitted to both countries using the same technology. The modifications were aimed at reducing the costs associated with meeting different technical requirements imposed by the two regulators.
“As Health Canada continues to move towards a common submission intake process and stay aligned with other leading regulatory authorities, eCTD format will progressively become the mandatory format for the majority of dossiers and regulatory activities filed to Health Canada,” the regulator wrote in opening the consultation Monday on the mandatory requirements—outlined in the notice. These include providing a sample according to established guidelines before submitting eCTD DMFs.
The decision follows on the heels of FDA final guidance—released last month—in which the deadline for drugmakers to implement eCTD requirements—set forth under the FD&C Act—was extended for an additional year through 5 May 2019 for Type III DMFs.
Consultation for Mandatory Requirements of using Electronic Common Technical Document (eCTD) Format when Submitting Master Files (MFs)