New AU eCTD Guidance

Australia has published their long-awaited eCTD guidance:

The AU M1 guidance bears a strong resemblance to EU Module 1 Specification. 

I noticed a few interesting items in the Guidance for Industry:

  • Section 4.1 allows for Word or RFT to be submitted in addition to PDF for general narrative documents (not just in M1 and M2).  This is considered a review aid, but in this case both documents are stored together in the eCTD (presumably linked into the backbone), not stored separately outside the eCTD such as is the case with MS Word for M1 and M2 in EU.  The AU guidance seems to imply that M1/M2 Word documents are stored outside the eCTD as in EU – it’s a little unclear as to whether these can be linked into the backbone.
  • Section 4.4 includes a list of documents that must be text searchable, and a list of documents that do not need to be text searchable.  To my knowledge, this has not been required in the past for eCTD, only for NeeS (with the possible exception of a few individual authorities in Europe).  Some companies will need to update their procedures to OCR key documents – although of course it’s better to create them from MS Word source in the first place.

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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