Notice - Preparation of Division 8 Regulatory Activities in the "Non-eCTD Electronic-Only" Format

March 2, 2016
Our file number: 16-100981-691

Health Canada is pleased to announce the acceptance of Division 8 regulatory activities for human drugs in "non-eCTD electronic-only" format. This Notice serves as a replacement to the Release of Health Canada's Revisions to"1.6 Electronic Review Documents" in Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format and The new requirements for submitting administrative drug submissions to Health Canada.

As part of an ongoing efficiency measure and efforts to reduce regulatory burden on industry as well as to transition to an electronic environment, Health Canada is proposing the following options for filing regulatory activities (such as NDS, SNDS, ANDS, NC, etc.) and related transactions pursuant to Section C, Division 8 of the Food and Drugs Regulations:

• Health Canada has been accepting regulatory activities in electronic Common Technical Document (eCTD) format since 2004. Therefore, the recommended option is to file regulatory activities or transactions in the eCTD format (where applicable). Refer to the Guidance Document: Preparation of Regulatory Activities in the electronic Common Technical Document (eCTD) Format, for further information.
• If a company is not ready to file in the eCTD format, they may file regulatory activities or transactions in the "non-eCTD electronic-only" format as an interim option until transition to the eCTD format has been completed. Refer to the Guidance Document: Preparation of Drug Regulatory Activities in "Non-eCTD Electronic-Only" Format for further information.

Electronic documents filed using any of the above options will be uploaded onto the Health Canada viewing tool, where they will be immediately accessible to Health Canada staff involved in the review of the regulatory activities. This will contribute to effective record management and ensure authenticity, integrity, availability, traceability, and non-repudiation of the data.

As of June 1st, 2016, Health Canada will no longer accept paper copies of transactions related to the above regulatory activities.

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 in scope of the Guidance Document: Preparation of Drug Regulatory Activities in the eCTD Format. This is to keep aligned with other regulatory authorities such as Food and Drug Administration (FDA) and European Medicines Agency (EMA). Questions or comments regarding this advanced notice can be sent to ereview@hc-sc.gc.ca.

Questions related to this notice may be directed via email to ereview@hc-sc.gc.ca.