Health Canada eCTD Format & Technical Requirements

We hope you have taken necessary inputs on Health Canada (HC) eCTD format and its content structure from our previous write up. In addition to the file format and content structure, it is equally important for applicants to decode the technical requirements which embody a core portion of successful submissions which enable quick review and approval processes. In view of catering the best of Regulatory information as a last-minute update to Health Canada’s eCTD deadline, i.e. Jan 1st, 2018, below are the technical requirements we have decoded from the Canadian health agency’s guidance.

There are categorical specifications and a brief assertion of the requirements are as follows:

1. File Formats: Keeping with the International Conference on Harmonisation (ICH’s) understanding of eCTD, the HC also mandates PDF format of the documents. Additionally, HC requires Microsoft Word 2010 (.docx) format for selected set of documents.

  • Documents that are to be provided in PDF and/or Microsoft Word 2010 (.docx) format are,

i. Product Monograph (PM):

  • The annotated version – should be provided in both formats
  • The non-annotated and the pristine version –Microsoft® Word 2010
  • The second language version - PDF

ii. Certified Product Information Document (CPID):

  • The annotated version - PDF
  • The non-annotated version - Microsoft Word 2010 format

iii. Summary Basis of Decision (SBD):

  • The clean version - PDF
  • The annotated (redlined) version - Microsoft Word 2010 format

iv. Few common documents which need to be in both PDF and Microsoft Word 2010 format

  • Quality Overall Summary (QOS)
  • Sponsor Attestation Checklist for ANDS
  • Label Safety Assessment Update - Sponsor Attestation
  • Dear Healthcare Professional Letter
  • Public Communication
  • Responses for clarification request, SDN, NON, and NOD

2. Transmission of Electronic Data in eCTD Format: It is widely known, and recommended by HC that the electronic data in eCTD format be provided through CESG (Common Electronic Submission Gateway).  But in case, the document is not accepted via CESG, the following media formats are acceptable without password protection:

  • Compact Disc-Recordable (CD-R) - Joliet specification
  • Digital Versatile Disc-Random Access Memory (DVD-RAM) - Universal Disc Format (UDF) standard
  • Single and dual layer Recordable Digital Versatile Discs
  • Single and dual layer Blu-ray discs
  • Universal Serial Bus (USB) 2.0 or 3.0 drive (non-returnable)
  • Portable External Hard Drive with USB 2.0 or 3.0 interface (non-returnable)

3. Life Cycle Management (LCM): When dealing with a Regulatory activity in eCTD format, it is important to establish a proper relation between the same and the life cycle of its dossier. Thus, the health agency would be able to access the location of an activity in the LCM document, HC outlines handling life cycle in three layers, where upon, specs are laid out to arrange each layer.

  • Dossier Layer (the guidance clearly depicts it)
  • Regulatory Activity Layer (the guidance clearly depicts it)
  • Document Layer

4. Bookmarks: The agency also suggests that the PDF files should be properly bookmarked in sections, subsections, tables, figures and appendices not exceeding the levels such as: heading, subheading, sub-subheading, sub-sub-subheading.

5. Hyperlinks & Cross-References: To facilitate good navigation through documents which enable quick review and approval processes, hyperlinks & cross-references should be added throughout, however not mentioning too many. Hyperlinks are exempted for word-processed documents.

With the transition period coming to an end, being informed and prepared is essential. Apart from technical requirements mentioned above, the Health Canada’s eCTD guidance details many procedural insights to be followed. To decode them in detail it is suggested to consult a proven publishing and submission partner.