Common Technical Document (CTD)

Consultation for Mandatory Requirements of using Electronic Common Technical Document (eCTD) Format when Submitting Master Files (MFs) [2018-05-07]
Notice: Introduction of the Regulatory Enrolment Process (REP) and the Use of the Common Electronic Submission Gateway (CESG) for Medical Devices [2018-01-03]
Notice: eCTD Pilot for Clinical Trial Regulatory Activities - Extension [2017-12-19]
Notice: Validation rules for regulatory transactions provided to Health Canada in the “non-eCTD electronic-only” format [2017-07-28]
Notice Applications for Investigational Testing Authorization (ITA), for Medical Devices, in the "Non-eCTD Electronics-Only" Format [2017-01-03]
Updated - Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" Format [2016-12-14]
Notice: Preparation of Clinical Trial Regulatory Activities in the "Non-eCTD Electronic-Only" Format [2016-11-30]
Notice - Instructions for Submitting Drug Notification Forms (DNF) and Supporting Documents Provided in Electronic Format [2016-03-02]
Notice - Re: Preparation of Drug Master File (DMF) in "Non-eCTD Electronic-Only" Format [2015-10-05]
Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format [2012-06-22]
Notice - Preparation of Division 8 Regulatory Activities in the Non-eCTD Electronic-Only Format [2016-03-02]
Draft Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format [2004-05-12]
Guidance for Clinical Trial Sponsors: Clinical Trial Applications [2003-06-25]
Templates