Posted 25 June 2012
By Alexander Gaffney
Regulators at Health Canada have announced the finalization of guidance intended to assist sponsors in preparing electronic common technical documents (eCTDs) to submit their pharmaceutical dossiers to the agency.
Health Canada said in April 2012 it is moving entirely to an eCTD format for all applications of pharmaceutical products after the non-eCTD applications were seen as a burden on the agency. "Health Canada is considering ending the Non-eCTD Hybrid Pilot at the end of March 2013 and would like to encourage sponsors to transition to the eCTD format as soon as possible to expedite the elimination of paper from the regulatory review process," the agency said in a statement in April.
While Health Canada's June announcement does not indicate the full transition of eCTD applications-Module 1 of the CTD will not be accepted in electronic form until Fall 2012, for instance-it is mandating that all documents submitted to the agency in electronic form continue to be updated and maintained electronically.
The guidance, effective 22 June 2012, will supersede an earlier 2003 draft guidance entitled, "Preparation of New Drug Submission in the CTD Format.
Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format
Regulatory Focus - Health Canada Looking to Transition all Submissions to eCTD Format