Australia Re-Releases M1 Guidance for CTD

In my last post, I mentioned new TGA eCTD information.  TGA has also updated CTD module 1 guidance.

The TGA has released a new version of Module 1: Administrative Information and Prescribing Information For Australia, dated November 2008. Fortunately this agency includes a nice Document Change Record at the beginning of the document. Changes include:

  • References to TGA organisation and titles updated
  •  Text amended to reflect changes in GMP clearance for prescription medicines as a result of the introduction of TGA eBusiness Services (Part B Module 1.7)
  • Addition of Module 1.13 Information relating to Pharmacovigilance (Part B Module 1.13)

Module 1.13 is entirely new. It consists of a Risk Management Plan for Australia, as outlined in Chapter 1.3 of EudraLex Volume 9A – Pharmacovigilance for Medicinal Products for Human Use (version September 2008).

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.

One Response

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  1. Nick Ward
    Nick Ward March 26, 2009 at 4:18 PM | |

    Hi Kathie, Agree the mandatory requirement for text searchable documents should not ordinarily be problematic if the source document is from MSWord etc..however also note that the TGA does not yet accept electronic signatures which means that such documents (eg test methods, validation reports etc.) that normally require signatures as a GLP requirement will mean that such documents will need to be OCR’d or include embedded signatures. Hopefully this will change in the near future!

    Regards,

    Nick Ward
    Regulatory Affairs Consultant

Please comment with your real name using good manners.

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