Update from the Regulators: Health Canada

Well,it’s back to business after the holiday break… and as promised, here’s my update on what’s happening at Health Canada.

At the recent DIA eSubmissions conference, Health Canada’s Vianney Caron presented an update on eCTD at Health Canada.

The E-Review Program

The purpose of Health Canada’s E-Review program is to support branch business processes throughout the health product life cycle across product lines using an integrated secure electronic environment that facilitates the exchange of information and conforms to international standards.

Health Canada has made a lot of progress in E-Review recently.  Important milestones achieved include:

  • Implementation of an electronic document management system (RDIMS) for Drug Master Files
  • Establishment of business process for receipt, validation, processing & storage of eCTDs, supported by SOPs
  • Initiation of a pilot providing remote users (e.g. teleworkers and external reviewers) access to electronic submissions via Citrix Web Office
  • Recent update of guidance documents (see my previous post Analysis: New, final Health Canada eCTD Guidance for Industry)

Regulatory Activities in eCTD Format

Metrics were provided on eCTDs received:

Cumulative through September of 2009:

  • Total number  of Dossiers: 205 (Pharmaceutical 182, Biologic 23)
  • Total number  of Regulatory Activities: 457 (Pharmaceutical 322, Biologic 126, Pharmacovigilance 9)
  • Total number  of Sequences: 2318

Totals for 2009 (as of September), received from 53 sponsors:

  • Total number  of Dossiers: 53 (59 in 2008)
  • Total number  of Regulatory Activities: 145 (151 in 2008)
  • Total number  of Sequences: 841 (748 in 2008)

Health Canada is not seeing a significant rise in applications and sequences received, such as has been experienced by the FDA and EMEA – perhaps because they still require at least part of the dossier in paper.  As of 2009, 8.7% of regulatory activities are received in eCTD format.

eCTD Validation

Sponsors are improving the quality of their submissions to Health Canada.  In 2009, 4.5% of sequences failed validation.  This is down considerably from previous years: 8.3% failed in 2008 and 11% failed in 2007.

Top 10 errors and warnings encountered during validation include:

1.    Inactive bookmarks -no link destination

2.    Inactive hyperlinks -no link destination

3.    External links -pointing to the folder or destination that does not exist in the folder structure on the CD/DVD. The folder or destination would only exist in the sponsor’s repository.

4.    Incorrect naming of the 3011 form; correct name is hc-sc-3011-en.pdf

5.    Unreferenced files in the index.xml or ca.regional.xml

6.    Life cycle management of the document: invalid file reference or no previous ID found

7.    Subfolders created in ca regional folder

8.    Missing top level folder

9.    Missing attestation letter; content as per eCTD Guidance, letter needs to be dated and signed

10. Printed content of MD-5 Checksum does not match the one in the index-md5.txt file

Preliminary Experience with eCTD

Health Canada reports that they have buy-in from all stakeholders, but no legal basis to make eCTD mandatory.  They continue to experience logistical and process issues.  Reviewers perceive that paper & electronic in parallel is difficult and the process is excessively manual.  Validation is perceived as an extra step.  Other review issues including understanding lifecycle management in the eCTD and dealing with scanned documents and resolution of graphics.

Some upcoming milestones include the retirement of hybrid submissions as of January 2010 (this month).  A date is yet to be announced for accepting fully electronic submissions.

Assessment of Hybrid Pilot

Health Canada surveyed reviewers participating in their hybrid pilot with some interesting results:

  • 41% say they are almost ready for submissions filed in the hybrid filing format, and 59% say they are totally ready
  • Using the electronic hybrid filing format, 44% of reviewers believed that their review/screening time remained the same and 39% believed that their review/screening time decreased.  50% believe that this format will save time in the future.
  • Reviewers recommended the following next steps: 47% wanted to continue the hybrid filing format, 24% wanted electronic only, and 29% wanted electronic only with Print on Demand
  • When asked if they would be comfortable with e-Only (no paper), 53 % would be very comfortable, 29% would be somewhat comfortable, and 18% would not very comfortable)

Next Steps at Health Canada

Health Canada defined their next steps as:

  • Opening the scope to more electronic submissions
  • Revising the DTD and guidance for the Canadian Module 1
  • Implementing two-way secure electronic communication (secure channel, secure email and gateway)
  • Improving their tracking system and integrating it with a workflow system
  • Strengthening international collaborations

Health Canada closed by saying that they strongly recommend electronic submissions in eCTD format, and support the development of common standards.  They will be expanding the existing infrastructure to support as many application types across product line as possible.  Questions can be sent to them at ereview@hc-sc.gc.ca.

Article written by

I am GlobalSubmit’s director of professional services. My area of expertise is electronic document management and regulatory submissions, specifically eCTD. I have 12 years of biopharmaceutical industry experience in the US, Europe, Israel and Japan, concentrating on content management for Regulatory Affairs & Submissions, Clinical Development, and Manufacturing, and in submission assembly and publishing. I have worked with over 50 pharmaceutical clients. Previously, I was the practice lead for the Subject Matter Experts/Business Analysts group at First Consulting Group (FCG), now part of CSC. I supervised a group of 12 SMEs/BAs. I was instrumental in the development of the FirstDoc® suite. I developed the project delivery methodology for FirstDoc® R&D, including training materials, project plans, workshop methodology and materials, and requirements and design specifications. I managed the design and development of FirstDoc® GMP and FirstDoc® Legal. Please feel free to contact me at kathleen.clark@globalsubmit.com if you are interested in talking about eCTD products or consulting services, or if you have ideas for the blog.

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