Notice: Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format

Notice

June 11, 2015

Our file number: 15-106452-344

Health Canada is pleased to announce the finalization of the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format. This guidance document replaces the Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format published in 2009. The revised guidance document will assist sponsors in the preparation of regulatory activities in the eCTD format developed by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Health Canada strongly recommends that, where possible, electronic data in eCTD format be submitted via the Common Electronic Submissions Gateway (CESG). See Health Canada's guide on How to use the Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada and Frequently Asked Questions.

The Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format reflects comments received from stakeholders. The implementation and use of the eCTD format is a work in progress. Future refinements and subsequent iterations of this guidance document will continue to be necessary as a result of efforts to further harmonize Canadian practice with international standards.

Any updates to eCTD filing requirements will not be applied retroactively to regulatory activities pending review. Furthermore, sponsors may continue to follow the Health Canada guidance documents in effect prior to the date of release of this guidance document for regulatory activities in preparation that will be filed in the near future. Subsequent regulatory activities, however, should be compiled using the most recent guidance documents.

Section 5 "Important considerations when preparing regulatory activities in eCTD format" provides additional guidance for preparing regulatory activities in eCTD format. This new section has been developed to resolve current issues related to the items where errors have been encountered. Sponsors are asked to read this section of the guidance document carefully.

Health Canada would like to provide an advanced notice that an implementation date for the mandatory requirement of filing regulatory activities in eCTD format is currently being considered for regulatory activities inscope of the Guidance Document: Preparation of Drug Regulatory Activities in the eCTD Format. This is to keep aligned with other regulatory authorities such as FDA and EMA.

Questions or comments regarding this announcement or the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format can be sent to ereview@hc-sc.gc.ca.

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Health Canada
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